Cortrosyn
- Product NDC
- 0548-5900
- 11-digit product format
- 005485900
- Labeler code
- 0548
- Product ID
- 0548-5900_089a373b-a63a-4575-8065-fdef2fc6c575
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cosyntropin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Amphastar Pharmaceuticals, Inc.
- Application
- NDA016750
- Marketing category
- NDA
- Marketing start
- 2003-08-01
- Substance
- COSYNTROPIN
- Active strength
- .25 mg/mL
- Pharmacologic classes
- Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cortrosyn
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| COSYNTROPIN | .25 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 72YY86EA29 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0548-5900-00 | Cortrosyn | 1 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 9 |
| 0548-5900-00 | Cortrosyn | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Cosyntropin | ACTIVE INGREDIENT | 72YY86EA29 | CORTROSYN (COSYNTROPIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMPHASTAR PHARMACEUTICALS, INC.] | 4 | |
| Cosyntropin | ACTIVE MOIETY | 72YY86EA29 | CORTROSYN (COSYNTROPIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMPHASTAR PHARMACEUTICALS, INC.] | 4 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | CORTROSYN (COSYNTROPIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMPHASTAR PHARMACEUTICALS, INC.] | 4 | |
| Cosyntropin | ACTIVE INGREDIENT | 72YY86EA29 | CORTROSYN INJECTION, POWDER, FOR SOLUTION [GENERAL INJECTABLES & VACCINES, INC] | 3 | |
| Cosyntropin | ACTIVE MOIETY | 72YY86EA29 | CORTROSYN INJECTION, POWDER, FOR SOLUTION [GENERAL INJECTABLES & VACCINES, INC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0548-5900 | CORTROSYN (COSYNTROPIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMPHASTAR PHARMACEUTICALS, INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20250207_746856e9-3930-4f6a-b8e6-a03845d6dd0b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0548-5900-00 | 00548590000 | 10 VIAL in 1 CARTON (0548-5900-00) / 1 mL in 1 VIAL | 10 vial | 2003-08-01 | 0000-00-00 | No | No | Current |