Cortrosyn
- Product NDC
- 0404-9839
- 11-digit product format
- 004049839
- Labeler code
- 0404
- Product ID
- 0404-9839_2a4b497c-9753-436b-8dc2-93440ccf680e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cortrosyn
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; PARENTERAL
- Labeler
- Henry Schein, Inc.
- Application
- NDA016750
- Marketing category
- NDA
- Marketing start
- 2022-01-09
- 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 |
|---|
| 0404-9839-99 | Cortrosyn | 1 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 6 |
| 0404-9839-99 | Cortrosyn | 1 in 1 BAG | INJECTION, POWDER, LYOPHILIZED, | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9839 | CORTROSYN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HENRY SCHEIN, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240120_0c424fac-b114-41f6-aba8-cf710a34c26c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0404-9839-99 | 00404983999 | 1 VIAL in 1 BAG (0404-9839-99) / 1 mL in 1 VIAL | 1 vial | 2022-01-09 | 0000-00-00 | No | No | Current |