Register entryShortage reported
B. Braun US Pharmaceutical Manufacturing LLC
- Registered sites
- 3
- Drug products
- 94
- Live patents
- 3
- Countries
- 2
- Base
- United States
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingLabellingFinished drug manufacturePackagingsterilize
Sites
Facilities
3| Site | Location | Operations | FEI |
|---|---|---|---|
| B. Braun Melsungen Aktiengesellschaft | MelsungenGermany | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3008323105 |
| B. Braun US Pharmaceutical Manufacturing LLC | Daytona Beach, FLUnited States | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3014200891 |
| B. Braun US Pharmaceutical Manufacturing LLC | Irvine, CAUnited States | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 2021236 |
Alert
Products in shortage
19| Drug | Presentation | Availability |
|---|---|---|
| Amino Acid Injection | Plenamine, Injection, 0.15 (NDC 0264-4500-05) | Available |
| Amino Acid Injection | Plenamine, Injection, 0.15 (NDC 0264-4500-00) | Available |
| Amino Acid Injection | TrophAmine 10%, Injection, 0.1 (NDC 0264-1933-10) | Available |
| Dextrose Monohydrate 10% Injection | Dextrose Monohydrate 10%, Injection, 10 g/100 mL (NDC 0264-7520-00) | Available |
| Dextrose Monohydrate 10% Injection | Dextrose Monohydrate 10%, Injection, 10 g/100 mL (NDC 0264-7520-20) | Available |
| Dextrose Monohydrate 10% Injection | Dextrose Monohydrate 10%, Injection, 10 g/100 mL (NDC 0264-7520-10) | Available |
| Dextrose Monohydrate 5% Injection | Dextrose 5% In Plastic Container, Injection, 50 mg/1 mL (NDC 0264-1510-32) | Available |
| Dextrose Monohydrate 5% Injection | Dextrose Monohydrate 5%, Injection, 5 g/100 mL (NDC 0264-7510-20) | Available |
| Dextrose Monohydrate 5% Injection | Dextrose Monohydrate 5%, Injection, 5 g/100 mL (NDC 0264-7510-10) | Available |
| Dextrose Monohydrate 5% Injection | Dextrose 5% In Plastic Container, Injection, 50 mg/1 mL (NDC 0264-1510-31) | Available |
| Dextrose Monohydrate 5% Injection | Dextrose Monohydrate 5%, Injection, 5 g/100 mL (NDC 0264-7510-00) | Available |
| Dextrose Monohydrate 70% Injection | Dextrose Monohydrate 70%, Injection, 70 g/100 mL (NDC 0264-7387-50) | Available |
| Heparin Sodium Injection | Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container, Injection, 200 [USP'U]/100 mL (NDC 0264-9872-10) | Available |
| Heparin Sodium Injection | Heparin Sodium 2,000 Units in Sodium Chloride 0.9% in Plastic Container, Injection, 200 [USP'U]/100 mL (NDC 0264-9872-00) | Available |
| Lidocaine Hydrochloride Injection | Lidocaine Hydrochloride And Dextrose, Injection, 5 g/100 mL; .4 g/100 mL (NDC 0264-9594-10) | Available |
| Lidocaine Hydrochloride Injection | Lidocaine Hydrochloride And Dextrose, Injection, 5 g/100 mL; .8 g/100 mL (NDC 0264-9598-20) | Available |
| Lidocaine Hydrochloride Injection | Lidocaine Hydrochloride And Dextrose, Injection, 5 g/100 mL; .4 g/100 mL (NDC 0264-9594-20) | Available |
| Sterile Water Irrigant | Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0264-2101-00) | Available |
| Sterile Water Irrigant | Sterile Water In Plastic Container, Irrigant, 1 mL/1 mL (NDC 0264-2101-10) | Available |
Exclusivity
Patents
3Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| CLOROTEKAL | CHLOROPROCAINE HYDROCHLORIDE | Sept 2026 |
| CLOROTEKAL | CHLOROPROCAINE HYDROCHLORIDE | Dec 2033 |
| ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | Jul 2039 |
Catalogue
Marketed products
94Showing 94 of 94.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| Acetaminophen | Acetaminophen | INJECTION | NDA |
| Acetaminophen | Acetaminophen | INJECTION | NDA |
| Acetic Acid | Acetic Acid | IRRIGANT | NDA |
| Balanced Salt | Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate | SOLUTION | ANDA |
| Bupivacaine Hydrochloride with Dextrose | Bupivacaine Hydrochloride with Dextrose | INJECTION | ANDA |
| CEFEPIME HYDROCHLORIDE AND DEXTROSE | CEFEPIME HYDROCHLORIDE | INJECTION, SOLUTION | NDA |
| CEFEPIME HYDROCHLORIDE AND DEXTROSE | CEFEPIME HYDROCHLORIDE | INJECTION, SOLUTION | NDA |
| CEFTRIAXONE AND DEXTROSE | CEFTRIAXONE | INJECTION, SOLUTION | NDA |
| CEFTRIAXONE AND DEXTROSE | CEFTRIAXONE | INJECTION, SOLUTION | NDA |
| Calcium Gluconate | Calcium Gluconate | INJECTION, SOLUTION | ANDA |
| Cefazolin Sodium | Cefazolin Sodium | SOLUTION | NDA |
| Cefazolin Sodium | Cefazolin Sodium | SOLUTION | NDA |
| Cefazolin Sodium | Cefazolin Sodium | SOLUTION | NDA |
| Cefoxitin and Dextrose | CEFOXITIN SODIUM | INJECTION, SOLUTION | NDA |
| Cefoxitin and Dextrose | CEFOXITIN SODIUM | INJECTION, SOLUTION | NDA |
| Cefuroxime and Dextrose | CEFUROXIME AND DEXTROSE | INJECTION, SOLUTION | NDA |
| Cefuroxime and Dextrose | CEFUROXIME AND DEXTROSE | INJECTION, SOLUTION | NDA |
| DEXTROSE | DEXTROSE | SOLUTION | NDA |
| DEXTROSE | DEXTROSE | SOLUTION | NDA |
| Dextrose | Dextrose | INJECTION, SOLUTION | NDA |
| Dextrose | Dextrose | SOLUTION | NDA |
| Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | INJECTION, SOLUTION | NDA |
| Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | INJECTION, SOLUTION | NDA |
| Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | INJECTION, SOLUTION | NDA |
| Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | INJECTION, SOLUTION | NDA |
| Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | INJECTION, SOLUTION | NDA |
| Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | INJECTION, SOLUTION | NDA |
| Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | INJECTION, SOLUTION | NDA |
| Dextrose in Lactated Ringers | DEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE | INJECTION, SOLUTION | NDA |
| Glycine | Glycine | IRRIGANT | NDA |
| Heparin Sodium in Dextrose | Heparin Sodium and Dextrose | INJECTION | NDA |
| Heparin Sodium in Dextrose | Heparin Sodium and Dextrose | INJECTION | NDA |
| Heparin Sodium in Dextrose | Heparin Sodium and Dextrose | INJECTION | NDA |
| Heparin Sodium in Sodium Chloride | Heparin Sodium in Sodium Chloride | INJECTION | NDA |
| Heparin Sodium in Sodium Chloride | Heparin Sodium in Sodium Chloride | INJECTION | NDA |
| Heparin Sodium in Sodium Chloride | Heparin Sodium in Sodium Chloride | INJECTION | NDA |
| Isolyte P in Dextrose | Dextrose, Sodium Acetate, Potassium Chloride, Magnesium Chloride, and Potassium Phosphate, Dibasic | INJECTION, SOLUTION | NDA |
| Isolyte S | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDE | INJECTION, SOLUTION | NDA |
| Isolyte S pH 7.4 | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM PHOSPHATE | INJECTION, SOLUTION | NDA |
| LIDOCAINE HCl and EPINEPHRINE | LIDOCAINE HCl and EPINEPHRINE | INJECTION | ANDA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | INJECTION | ANDA |
| Lactated Ringers | Sodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium Chloride | IRRIGANT | NDA |
| Lactated Ringers | Sodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium Chloride | INJECTION, SOLUTION | NDA |
| Lactated Ringers Irrigation | sodium chloride, sodium lactate, potassium chloride and calcium chloride | SOLUTION | NDA |
| Levetiracetam | Levetiracetam | INJECTION | ANDA |
| Levetiracetam | Levetiracetam | INJECTION | ANDA |
| Levetiracetam | Levetiracetam | INJECTION | ANDA |
| Lidocaine Hydrochloride and Dextrose | LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE | INJECTION, SOLUTION | NDA |
| Lidocaine Hydrochloride and Dextrose | LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE | INJECTION, SOLUTION | NDA |
| METRONIDAZOLE | METRONIDAZOLE | SOLUTION | NDA |
| MIDAZOLAM IN 0.8% SODIUM CHLORIDE | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | INJECTION, SOLUTION | ANDA |
| MIDAZOLAM IN 0.8% SODIUM CHLORIDE | MIDAZOLAM IN 0.8% SODIUM CHLORIDE | INJECTION, SOLUTION | ANDA |
| Magnesium Sulfate in Dextrose | magnesium sulfate heptahydrate | INJECTION, SOLUTION | ANDA |
| Magnesium Sulfate in Water | magnesium sulfate heptahydrate | INJECTION, SOLUTION | ANDA |
| Magnesium Sulfate in Water | magnesium sulfate heptahydrate | INJECTION, SOLUTION | ANDA |
| Magnesium Sulfate in Water | magnesium sulfate heptahydrate | INJECTION, SOLUTION | ANDA |
| Mannitol | MANNITOL | INJECTION, SOLUTION | NDA |
| Meropenem and Sodium Chloride | Meropenem and Sodium Chloride | INJECTION, SOLUTION | NDA |
| Meropenem and Sodium Chloride | Meropenem and Sodium Chloride | INJECTION, SOLUTION | NDA |
| NutriLipid I.V. Fat Emulsion | Soybean Oil | INJECTION, SOLUTION | NDA |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | INJECTION, SOLUTION, CONCENTRATE | ANDA |
| POTASSIUM CHLORIDE IN DEXTROSE | DEXTROSE and POTASSIUM CHLORIDE | SOLUTION | NDA |
| POTASSIUM CHLORIDE IN SODIUM CHLORIDE | SODIUM CHLORIDE and POTASSIUM CHLORIDE | SOLUTION | NDA |
| Physiolyte | Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, and Magnesium Chloride | IRRIGANT | NDA |
| Piperacillin and Tazobactam and Sodium Chloride | Piperacillin and Tazobactam and Sodium Chloride | INJECTION, SOLUTION | NDA |
| Piperacillin and Tazobactam and Sodium Chloride | Piperacillin and Tazobactam and Sodium Chloride | INJECTION, SOLUTION | NDA |
| Piperacillin and Tazobactam and Sodium Chloride | Piperacillin and Tazobactam and Sodium Chloride | INJECTION, SOLUTION | NDA |
| Plenamine | LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE | SOLUTION | ANDA |
| Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE | INJECTION | NDA |
| Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE | INJECTION | NDA |
| Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE | INJECTION | NDA |
| Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE | INJECTION | NDA |
| Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE | INJECTION | NDA |
| Potassium Chloride in Dextrose and Sodium Chloride | DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE | INJECTION | NDA |
| Ringers | Sodium Chloride, Potassium Chloride, and Calcium Chloride | IRRIGANT | NDA |
| Ringers | Sodium Chloride, Calcium Chloride, and Potassium Chloride | INJECTION, SOLUTION | NDA |
| Rocuronium Bromide | Rocuronium Bromide | INJECTION | NDA |
| Sodium Chloride | Sodium Chloride | INJECTION, SOLUTION | NDA |
| Sodium Chloride | Sodium Chloride | IRRIGANT | NDA |
| Sodium Chloride | SODIUM CHLORIDE | INJECTION, SOLUTION | NDA |
| Sodium Chloride | SODIUM CHLORIDE | INJECTION, SOLUTION | NDA |
| Sodium Chloride | SODIUM CHLORIDE | INJECTION, SOLUTION | NDA |
| Sodium Chloride | SODIUM CHLORIDE | INJECTION, SOLUTION | NDA |
| Sodium Chloride | Sodium Chloride | INJECTION, SOLUTION | NDA |
| Sodium Chloride | Sodium Chloride | INJECTION, SOLUTION | NDA |
| Sodium Chloride | Sodium Chloride | INJECTION | NDA |
| Sodium Chloride for Irrigation | Sodium Chloride for Irrigation | SOLUTION | NDA |
| Sterile Water | Water | IRRIGANT | NDA |
| Sterile Water | Water | INJECTION | NDA |
| Sterile Water | Sterile Water | IRRIGANT | NDA |
| Sterile Water | Water | INJECTION | NDA |
| Sugammadex | Sugammadex | INJECTION | ANDA |
| TROMETHAMINE | TROMETHAMINE | INJECTION, SOLUTION | ANDA |
| 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 | NDA |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.