Register entryShortage reported
B. Braun US Pharmaceutical Manufacturing LLC
Data as of · How to read this entry
- Registered sites
- 3
- Active NDC listings
- 94
- Live patents
- 2
- Shortage listings
- 19
- Countries
- 2
- Base
- United States
Authorisation
Registered operations
Analytical testing3Labelling3Finished drug manufacture3Packaging3sterilize3
Sites
Registered establishments
3| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| B. Braun Melsungen AktiengesellschaftRegistrant: B. Braun Medical Inc. | Am Schwerzelshof 1, Melsungen, 34212, Germany (DEU) | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3008323105312949429 |
| B. Braun US Pharmaceutical Manufacturing LLC | 1845 Mason Ave, Daytona Beach, Florida (FL) 32117, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3014200891837802177 |
| B. Braun US Pharmaceutical Manufacturing LLC | 2525 McGaw Avenue, Irvine, California (CA) 92614, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 2021236037425308 |
Alert
Drug shortage listings
19| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Amino Acid InjectionGastroenterology | Plenamine, Injection, 0.15 (NDC 0264-4500-05) | Current | Available | 8 Dec 202022 Sept 2026 |
| Amino Acid InjectionGastroenterology | Plenamine, Injection, 0.15 (NDC 0264-4500-00) | Current | Available | 8 Dec 202022 Sept 2026 |
| Amino Acid InjectionGastroenterology | TrophAmine 10%, Injection, 0.1 (NDC 0264-1933-10) | Current | Available | 8 Dec 202022 Sept 2026 |
| Dextrose Monohydrate 10% InjectionEndocrinology/Metabolism, Gastroenterology, Other, Pediatric | Dextrose Monohydrate 10%, Injection, 10 g/100 mL (NDC 0264-7520-10) | Current | Available | 1 Mar 202222 Sept 2026 |
| Dextrose Monohydrate 10% InjectionEndocrinology/Metabolism, Gastroenterology, Other, Pediatric | Dextrose Monohydrate 10%, Injection, 10 g/100 mL (NDC 0264-7520-00) | Current | Available | 1 Mar 202222 Sept 2026 |
| Dextrose Monohydrate 10% InjectionEndocrinology/Metabolism, Gastroenterology, Other, Pediatric | Dextrose Monohydrate 10%, Injection, 10 g/100 mL (NDC 0264-7520-20) | Current | Available | 1 Mar 202222 Sept 2026 |
| Dextrose Monohydrate 5% InjectionEndocrinology/Metabolism, Gastroenterology, Other, Pediatric | Dextrose Monohydrate 5%, Injection, 5 g/100 mL (NDC 0264-7510-20) | Current | Available | 14 Feb 202222 Sept 2026 |
| Dextrose Monohydrate 5% InjectionEndocrinology/Metabolism, Gastroenterology, Other, Pediatric | Dextrose 5% In Plastic Container, Injection, 50 mg/1 mL (NDC 0264-1510-32) | Current | Available | 14 Feb 202222 Sept 2026 |
| Dextrose Monohydrate 5% InjectionEndocrinology/Metabolism, Gastroenterology, Other, Pediatric | Dextrose 5% In Plastic Container, Injection, 50 mg/1 mL (NDC 0264-1510-31) | Current | Available | 14 Feb 202222 Sept 2026 |
| Dextrose Monohydrate 5% InjectionEndocrinology/Metabolism, Gastroenterology, Other, Pediatric | Dextrose Monohydrate 5%, Injection, 5 g/100 mL (NDC 0264-7510-10) | Current | Available | 14 Feb 202222 Sept 2026 |
| Dextrose Monohydrate 5% InjectionEndocrinology/Metabolism, Gastroenterology, Other, Pediatric | Dextrose Monohydrate 5%, Injection, 5 g/100 mL (NDC 0264-7510-00) | Current | Available | 14 Feb 202222 Sept 2026 |
| Dextrose Monohydrate 70% InjectionEndocrinology/Metabolism, Gastroenterology, Other, Pediatric | Dextrose Monohydrate 70%, Injection, 70 g/100 mL (NDC 0264-7387-50) | Current | Available | 11 Oct 202422 Sept 2026 |
| Heparin Sodium InjectionHematology | Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container, Injection, 200 [USP'U]/100 mL (NDC 0264-9872-10) | Current | Limited Availability | 14 Nov 201722 Sept 2026 |
| Heparin Sodium InjectionHematology | Heparin Sodium 2,000 Units in Sodium Chloride 0.9% in Plastic Container, Injection, 200 [USP'U]/100 mL (NDC 0264-9872-00) | Current | Limited Availability | 14 Nov 201722 Sept 2026 |
| Lidocaine Hydrochloride InjectionCardiovascular | Lidocaine Hydrochloride And Dextrose, Injection, 5 g/100 mL; .4 g/100 mL (NDC 0264-9594-10) | Current | Available | 25 Oct 201722 Sept 2026 |
| Lidocaine Hydrochloride InjectionCardiovascular | Lidocaine Hydrochloride And Dextrose, Injection, 5 g/100 mL; .8 g/100 mL (NDC 0264-9598-20) | Current | Available | 25 Oct 201722 Sept 2026 |
| Lidocaine Hydrochloride InjectionCardiovascular | Lidocaine Hydrochloride And Dextrose, Injection, 5 g/100 mL; .4 g/100 mL (NDC 0264-9594-20) | Current | Available | 25 Oct 201722 Sept 2026 |
| Sterile Water IrrigantGastroenterology, Other, Pediatric | Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0264-2101-00) | Current | Available | 28 Apr 202322 Sept 2026 |
| Sterile Water IrrigantGastroenterology, Other, Pediatric | Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0264-2101-10) | Current | Available | 28 Apr 202322 Sept 2026 |
Catalogue
Drug listings by form and route
9494 active NDC listings: 94 human prescription drug. By marketing category: NDA 76, ANDA 18.
| Dosage form | NDCs |
|---|---|
| injection, solution | 46 |
| injection | 25 |
| solution | 14 |
| irrigant | 8 |
| injection, solution, concentrate | 1 |
| Route | NDCs |
|---|---|
| intravenous | 79 |
| irrigation | 11 |
| infiltration | 2 |
| epidural | 1 |
| intracaudal | 1 |
| parenteral | 1 |
| perineural | 1 |
| subarachnoid | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| b. braun medical inc. | 94 |
Exclusivity
Patents and exclusivities
2| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 9504666 | CLOROTEKALchloroprocaine hydrochloride | product | Dec 2033 |
| 11998605 | ROCURONIUM BROMIDErocuronium bromide | product | Jul 2039 |
Catalogue
Marketed products
94| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Acetaminophen | Acetaminophen | injection, intravenous | 0264-4050NDA |
| Acetaminophen | Acetaminophen | injection, intravenous | 0264-4100NDA |
| Acetic Acid | Acetic Acid | irrigant, irrigation | 0264-2304NDA |
| Balanced Salt | Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate | solution, irrigation | 0264-1945ANDA |
| Bupivacaine Hydrochloride with Dextrose | Bupivacaine Hydrochloride with Dextrose | injection, subarachnoid | 0264-9379ANDA |
| CEFEPIME HYDROCHLORIDE AND DEXTROSE | CEFEPIME HYDROCHLORIDE | injection, solution, intravenous | 0264-3193NDA |
| CEFEPIME HYDROCHLORIDE AND DEXTROSE | CEFEPIME HYDROCHLORIDE | injection, solution, intravenous | 0264-3195NDA |
| CEFTRIAXONE AND DEXTROSE | CEFTRIAXONE | injection, solution, intravenous | 0264-3153NDA |
| CEFTRIAXONE AND DEXTROSE | CEFTRIAXONE | injection, solution, intravenous | 0264-3155NDA |
| Calcium Gluconate | Calcium Gluconate | injection, solution, intravenous | 0264-5600ANDA |
| Cefazolin Sodium | Cefazolin Sodium | solution, intravenous | 0264-3103NDA |
| Cefazolin Sodium | Cefazolin Sodium | solution, intravenous | 0264-3105NDA |
| Cefazolin Sodium | Cefazolin Sodium | solution, intravenous | 0264-3107NDA |
| Cefoxitin and Dextrose | CEFOXITIN SODIUM | injection, solution, intravenous | 0264-3123NDA |
| Cefoxitin and Dextrose | CEFOXITIN SODIUM | injection, solution, intravenous | 0264-3125NDA |
| Cefuroxime and Dextrose | CEFUROXIME AND DEXTROSE | injection, solution, intravenous | 0264-3112NDA |
| Cefuroxime and Dextrose | CEFUROXIME AND DEXTROSE | injection, solution, intravenous | 0264-3114NDA |
| DEXTROSE | DEXTROSE | solution, intravenous | 0264-7510NDA |
| DEXTROSE | DEXTROSE | solution, intravenous | 0264-7520NDA |
| Dextrose | Dextrose | injection, solution, intravenous | 0264-1510NDA |
| Dextrose | Dextrose | solution, intravenous | 0264-7387NDA |
| Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | injection, solution, intravenous | 0264-7608NDA |
| Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | injection, solution, intravenous | 0264-7610NDA |
| Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | injection, solution, intravenous | 0264-7612NDA |
| Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | injection, solution, intravenous | 0264-7614NDA |
| Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | injection, solution, intravenous | 0264-7616NDA |
| Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | injection, solution, intravenous | 0264-7622NDA |
| Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | injection, solution, intravenous | 0264-7623NDA |
| Dextrose in Lactated Ringers | DEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE | injection, solution, intravenous | 0264-7751NDA |
| Glycine | Glycine | irrigant, irrigation | 0264-7390NDA |
| Heparin Sodium in Dextrose | Heparin Sodium and Dextrose | injection, intravenous | 0264-9567NDA |
| Heparin Sodium in Dextrose | Heparin Sodium and Dextrose | injection, intravenous | 0264-9577NDA |
| Heparin Sodium in Dextrose | Heparin Sodium and Dextrose | injection, intravenous | 0264-9587NDA |
| Heparin Sodium in Sodium Chloride | Heparin Sodium in Sodium Chloride | injection, intravenous | 0264-3301NDA |
| Heparin Sodium in Sodium Chloride | Heparin Sodium in Sodium Chloride | injection, intravenous | 0264-3462NDA |
| Heparin Sodium in Sodium Chloride | Heparin Sodium in Sodium Chloride | injection, intravenous | 0264-9872NDA |
| Isolyte P in Dextrose | Dextrose, Sodium Acetate, Potassium Chloride, Magnesium Chloride, and Potassium Phosphate, Dibasic | injection, solution, intravenous | 0264-7730NDA |
| Isolyte S | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDE | injection, solution, intravenous | 0264-7703NDA |
| Isolyte S pH 7.4 | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM PHOSPHATE | injection, solution, intravenous | 0264-7707NDA |
| LIDOCAINE HCl and EPINEPHRINE | LIDOCAINE HCl and EPINEPHRINE | injection, epidural, infiltration, intracaudal, perineural | 0264-9378ANDA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | injection, infiltration | 0264-9376ANDA |
| Lactated Ringers | Sodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium Chloride | irrigant, irrigation | 0264-2203NDA |
| Lactated Ringers | Sodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium Chloride | injection, solution, intravenous | 0264-7750NDA |
| Lactated Ringers Irrigation | sodium chloride, sodium lactate, potassium chloride and calcium chloride | solution, irrigation | 0264-7389NDA |
| Levetiracetam | Levetiracetam | injection, intravenous | 0264-1009ANDA |
| Levetiracetam | Levetiracetam | injection, intravenous | 0264-1509ANDA |
| Levetiracetam | Levetiracetam | injection, intravenous | 0264-5009ANDA |
| Lidocaine Hydrochloride and Dextrose | LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE | injection, solution, intravenous | 0264-9594NDA |
| Lidocaine Hydrochloride and Dextrose | LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE | injection, solution, intravenous | 0264-9598NDA |
| METRONIDAZOLE | METRONIDAZOLE | solution, intravenous | 0264-5535NDA |
| MIDAZOLAM IN 0.8% SODIUM CHLORIDE | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | injection, solution, intravenous | 0264-8002ANDA |
| MIDAZOLAM IN 0.8% SODIUM CHLORIDE | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | injection, solution, intravenous | 0264-8005ANDA |
| Magnesium Sulfate in Dextrose | magnesium sulfate heptahydrate | injection, solution, intravenous | 0264-4400ANDA |
| Magnesium Sulfate in Water | magnesium sulfate heptahydrate | injection, solution, intravenous | 0264-4204ANDA |
| Magnesium Sulfate in Water | magnesium sulfate heptahydrate | injection, solution, intravenous | 0264-4205ANDA |
| Magnesium Sulfate in Water | magnesium sulfate heptahydrate | injection, solution, intravenous | 0264-4206ANDA |
| Mannitol | MANNITOL | injection, solution, intravenous | 0264-7578NDA |
| Meropenem and Sodium Chloride | Meropenem and Sodium Chloride | injection, solution, intravenous | 0264-3183NDA |
| Meropenem and Sodium Chloride | Meropenem and Sodium Chloride | injection, solution, intravenous | 0264-3185NDA |
| NutriLipid I.V. Fat Emulsion | Soybean Oil | injection, solution, intravenous | 0264-4460NDA |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | injection, solution, concentrate, parenteral | 0264-1944ANDA |
| POTASSIUM CHLORIDE IN DEXTROSE | DEXTROSE and POTASSIUM CHLORIDE | solution, intravenous | 0264-7625NDA |
| POTASSIUM CHLORIDE IN SODIUM CHLORIDE | SODIUM CHLORIDE and POTASSIUM CHLORIDE | solution, intravenous | 0264-7865NDA |
| Physiolyte | Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, and Magnesium Chloride | irrigant, irrigation | 0264-2205NDA |
| Piperacillin and Tazobactam and Sodium Chloride | Piperacillin and Tazobactam and Sodium Chloride | injection, solution, intravenous | 0264-3446NDA |
| Piperacillin and Tazobactam and Sodium Chloride | Piperacillin and Tazobactam and Sodium Chloride | injection, solution, intravenous | 0264-3448NDA |
| Piperacillin and Tazobactam and Sodium Chloride | Piperacillin and Tazobactam and Sodium Chloride | injection, solution, intravenous | 0264-3450NDA |
| Plenamine | LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE | solution, intravenous | 0264-4500ANDA |
| Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE | injection, intravenous | 0264-7634NDA |
| Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE | injection, intravenous | 0264-7635NDA |
| Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE | injection, intravenous | 0264-7636NDA |
| Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE | injection, intravenous | 0264-7638NDA |
| Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE | injection, intravenous | 0264-7645NDA |
| Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE | injection, intravenous | 0264-7652NDA |
| Ringers | Sodium Chloride, Potassium Chloride, and Calcium Chloride | irrigant, irrigation | 0264-2202NDA |
| Ringers | Sodium Chloride, Calcium Chloride, and Potassium Chloride | injection, solution, intravenous | 0264-7780NDA |
| Rocuronium Bromide | Rocuronium Bromide | injection, intravenous | 0264-5711NDA |
| Sodium Chloride | Sodium Chloride | injection, solution, intravenous | 0264-1800NDA |
| Sodium Chloride | Sodium Chloride | irrigant, irrigation | 0264-2201NDA |
| Sodium Chloride | SODIUM CHLORIDE | injection, solution, intravenous | 0264-5802NDA |
| Sodium Chloride | SODIUM CHLORIDE | injection, solution, intravenous | 0264-5804NDA |
| Sodium Chloride | Sodium Chloride | injection, solution, intravenous | 0264-7800NDA |
| Sodium Chloride | SODIUM CHLORIDE | injection, solution, intravenous | 0264-7802NDA |
| Sodium Chloride | Sodium Chloride | injection, solution, intravenous | 0264-7805NDA |
| Sodium Chloride | Sodium Chloride | injection, solution, intravenous | 0264-7806NDA |
| Sodium Chloride | Sodium Chloride | injection, intravenous | 0264-9375NDA |
| Sodium Chloride for Irrigation | Sodium Chloride for Irrigation | solution, irrigation | 0264-7388NDA |
| Sterile Water | Water | irrigant, irrigation | 0264-2101NDA |
| Sterile Water | Water | injection, intravenous | 0264-7385NDA |
| Sterile Water | Sterile Water | irrigant, irrigation | 0264-7386NDA |
| Sterile Water | Water | injection, intravenous | 0264-7850NDA |
| Sugammadex | Sugammadex | injection, intravenous | 0264-8200ANDA |
| TROMETHAMINE | TROMETHAMINE | injection, solution, intravenous | 0264-8031ANDA |
| TrophAmine | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE | solution, intravenous | 0264-1933NDA |
Neighbours
Registered in the same town
9- Spectrum Pharmaceuticals, Inc.Irvine, CA · 2 sites
- Siegfried USA, LLCIrvine, CA
- Allergan, Inc.Irvine, CA
- LGM Pharma Solutions, LLCIrvine, CA
- North American Science Associates, LLCIrvine, CA
- Reed Baileydaytona beach, FL
- Derma Care Research Labs, LLCDaytona Beach, FL
- Noble Panacea Labs, Inc.Irvine, CA
- Solupharm Pharmazeutische Erzeugnisse GmbHMelsungen, DEU
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Enquiry
Common questions
- Is B. Braun US Pharmaceutical Manufacturing LLC FDA approved?
- B. Braun US Pharmaceutical Manufacturing LLC holds 3 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are B. Braun US Pharmaceutical Manufacturing LLC's drugs manufactured?
- At registered sites in Germany, the United States. The FDA register lists Melsungen; Daytona Beach, FL; Irvine, CA. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, sterilize.
- What drugs does B. Braun US Pharmaceutical Manufacturing LLC make?
- 94 products are listed under B. Braun US Pharmaceutical Manufacturing LLC in the openFDA NDC Directory, most often as injection, solution; injection; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
- Are any B. Braun US Pharmaceutical Manufacturing LLC products in shortage?
- 19 presentations are currently listed in the FDA drug shortage database under B. Braun US Pharmaceutical Manufacturing LLC, covering Amino Acid Injection, Dextrose Monohydrate 10% Injection, Dextrose Monohydrate 5% Injection and 4 other drugs.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.