Register entryShortage reported
- Registered sites
- 1
- Active NDC listings
- 25
- Labeller names
- 3
- Live patents
- 17
- Shortage listings
- 3
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Analytical testing1Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1sterilize1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Exela Pharma Sciences, LLC.Registrant: Exela Pharma Sciences | 1245 Blowing Rock Blvd. 1325 William White Place 320 Cooperative Way 2101 Morganton Blvd 1201 Exela Way 1170 West Ave NW, Lenoir, North Carolina (NC) 28645, United States (USA) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, sterilize | 3008563008831274399 |
Alert
Drug shortage listings
3| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Sodium Bicarbonate InjectionEndocrinology/Metabolism, Gastroenterology, Pediatric | Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 51754-5001-5) | Current | Available | 24 Jul 20171 Oct 2026 |
| Sodium Bicarbonate InjectionEndocrinology/Metabolism, Gastroenterology, Pediatric | Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 51754-5011-4) | Current | Available | 24 Jul 20171 Oct 2026 |
| Sodium Bicarbonate InjectionEndocrinology/Metabolism, Gastroenterology, Pediatric | Sodium Bicarbonate, Injection, 42 mg/1 mL (NDC 51754-5012-4) | Current | Available | 24 Jul 20171 Oct 2026 |
Catalogue
Drug listings by form and route
2525 active NDC listings: 25 human prescription drug. By marketing category: NDA 14, ANDA 11.
| Dosage form | NDCs |
|---|---|
| injection, solution | 16 |
| injection | 8 |
| solution | 1 |
| Route | NDCs |
|---|---|
| intravenous | 24 |
| intramuscular | 4 |
| oral | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| exela pharma sciences, llc | 20 |
| exela pharma sciences, llc | 4 |
| exela pharma sciences,llc | 1 |
Exclusivity
Patents and exclusivities
17| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 9486530 | GANZYK-RTUganciclovir | product | Sept 2034 |
| 10478453 | ELCYScysteine hydrochloride | product | Jan 2039 |
| 10583155 | ELCYScysteine hydrochloride | product | Jan 2039 |
| 10653719 | ELCYScysteine hydrochloride | product | Jan 2039 |
| 10905713 | ELCYScysteine hydrochloride | product | Jan 2039 |
| 10905714 | ELCYScysteine hydrochloride | product | Jan 2039 |
| 10912795 | ELCYScysteine hydrochloride | product | Jan 2039 |
| 10918662 | ELCYScysteine hydrochloride | product | Jan 2039 |
| 10933089 | ELCYScysteine hydrochloride | product | Jan 2039 |
| 11510941 | ELCYScysteine hydrochloride | product | Jan 2039 |
| 11510942 | ELCYScysteine hydrochloride | product | Jan 2039 |
| 11642370 | ELCYScysteine hydrochloride | product | Jan 2039 |
| 11648262 | ELCYScysteine hydrochloride | product | Jan 2039 |
| 11679125 | ELCYScysteine hydrochloride | product | Jan 2039 |
| 11684636 | ELCYScysteine hydrochloride | product | Jan 2039 |
| 11826383 | ELCYScysteine hydrochloride | product | Jan 2039 |
| 11969439 | ELCYScysteine hydrochloride | use | Jan 2039 |
Catalogue
Marketed products
25| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Akovaz | ephedrine sulfate | injection, intravenous | 51754-4200NDA |
| Akovaz | ephedrine sulfate | injection, intravenous | 51754-4250NDA |
| Bloxiverz | Neostigmine Methylsulfate | injection, intravenous | 51754-1200NDA |
| CUPRIC CHLORIDE | cupric chloride | injection, solution, intravenous | 51754-0103ANDA |
| ELCYS | Cysteine Hydrochloride | injection, solution, intravenous | 51754-1007NDA |
| ELCYS | Cysteine Hydrochloride | injection, solution, intravenous | 51754-1008NDA |
| GLYRX-PF | glycopyrrolate | injection, solution, intramuscular, intravenous | 51754-6000NDA |
| GLYRX-PF | glycopyrrolate | injection, solution, intramuscular, intravenous | 51754-6001NDA |
| GLYRX-PF | glycopyrrolate | injection, solution, intramuscular, intravenous | 51754-6013NDA |
| GLYRX-PF | glycopyrrolate | injection, solution, intramuscular, intravenous | 51754-6015NDA |
| NIPRIDE RTU | Sodium Nitroprusside | injection, solution, intravenous | 51754-1006NDA |
| NIPRIDE RTU | Sodium Nitroprusside | injection, solution, intravenous | 51754-1029NDA |
| Potassium Acetate | Potassium Acetate | injection, intravenous | 51754-2004ANDA |
| Sodium Bicarbonate | SODIUM BICARBONATE | injection, solution, intravenous | 51754-5001ANDA |
| Sodium Bicarbonate | SODIUM BICARBONATE | injection, solution, intravenous | 51754-5002ANDA |
| Sodium Bicarbonate | SODIUM BICARBONATE | injection, solution, intravenous | 51754-5011ANDA |
| Sodium Bicarbonate | SODIUM BICARBONATE | injection, solution, intravenous | 51754-5012ANDA |
| Sodium Bicarbonate | SODIUM BICARBONATE | injection, solution, intravenous | 51754-8020ANDA |
| Sodium Bicarbonate | SODIUM BICARBONATE | injection, solution, intravenous | 51754-8888ANDA |
| TRANEXAMIC ACID IN SODIUM CHLORIDE | tranexamic acid | injection, solution, intravenous | 51754-0108NDA |
| Verapamil Hydrochloride | Verapamil Hydrochloride | injection, intravenous | 51754-0203NDA |
| Verapamil Hydrochloride | Verapamil Hydrochloride | injection, intravenous | 51754-0204NDA |
| Zinc Chloride | Zinc Chloride | injection, intravenous | 51754-0102ANDA |
| caffeine citrate | caffeine citrate | injection, intravenous | 51754-0500ANDA |
| caffeine citrate | CAFFEINE CITRATE | solution, oral | 51754-0501ANDA |
Neighbours
Registered in the same town
1- Greer Laboratories, Inc.Lenoir, NC
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Enquiry
Common questions
- Is Exela Pharma Sciences FDA approved?
- Exela Pharma Sciences holds 1 FDA-registered establishment in the United States. 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 Exela Pharma Sciences's drugs manufactured?
- The FDA register lists Lenoir, NC. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, sterilize.
- What drugs does Exela Pharma Sciences make?
- 25 products are listed under Exela Pharma Sciences 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 Exela Pharma Sciences products in shortage?
- 3 presentations are currently listed in the FDA drug shortage database under Exela Pharma Sciences, covering Sodium Bicarbonate Injection.
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.