NDC 0548-5900
Cortrosyn
Cosyntropin
Cortrosyn is a Intramuscular; Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Amphastar Pharmaceuticals, Inc.. The primary component is Cosyntropin.
| Product ID | 0548-5900_2116f568-69bb-4ed8-92ed-bd80ee412946 |
| NDC | 0548-5900 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Cortrosyn |
| Generic Name | Cosyntropin |
| Dosage Form | Injection, Powder, Lyophilized, For Solution |
| Route of Administration | INTRAMUSCULAR; INTRAVENOUS |
| Marketing Start Date | 2003-08-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA016750 |
| Labeler Name | Amphastar Pharmaceuticals, Inc. |
| Substance Name | COSYNTROPIN |
| Active Ingredient Strength | 0 mg/mL |
| Pharm Classes | Adrenocorticotropic Hormone [CS],Adrenocorticotropic Hormone [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 0548-5900-00
10 VIAL in 1 CARTON (0548-5900-00) > 1 mL in 1 VIAL
| Marketing Start Date | 2003-08-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0548-5900-00 [00548590000]
Cortrosyn INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
| Marketing Category | NDA |
| Application Number | NDA016750 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2003-08-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| COSYNTROPIN | .25 mg/mL |
OpenFDA Data
| SPL SET ID: | 746856e9-3930-4f6a-b8e6-a03845d6dd0b |
| Manufacturer | |
| UNII |
Pharmacological Class
- Adrenocorticotropic Hormone [CS]
- Adrenocorticotropic Hormone [EPC]
- Adrenocorticotropic Hormone [CS]
- Adrenocorticotropic Hormone [EPC]
NDC Crossover Matching brand name "Cortrosyn" or generic name "Cosyntropin"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0404-9839 | Cortrosyn | Cortrosyn |
| 0548-5900 | Cortrosyn | Cosyntropin |
| 50090-4547 | Cortrosyn | Cosyntropin |
| 52584-050 | Cortrosyn | Cortrosyn |
| 0781-3440 | Cosyntropin | Cosyntropin |
| 51662-1567 | COSYNTROPIN | COSYNTROPIN |
| 67457-227 | Cosyntropin | cosyntropin |
Trademark Results [Cortrosyn]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CORTROSYN 78761920 3165133 Live/Registered |
Amphastar Pharmaceuticals, Inc. 2005-11-28 |
 CORTROSYN 72186267 0779366 Dead/Expired |
ORGANON INC. 1964-02-07 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.