SOLU-CORTEF
- Product NDC
- 51662-1261
- 11-digit product format
- 516621261
- Labeler code
- 51662
- Product ID
- 51662-1261_1203ca7f-080b-4c49-e063-6294a90a90e0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SOLU-CORTEF
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- HF Acquisition Co. LLC, DBA HealthFirst
- Application
- NDA009866
- Marketing category
- NDA
- Marketing start
- 2018-09-03
- Substance
- HYDROCORTISONE SODIUM SUCCINATE
- Active strength
- 100 mg/2mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SOLU-CORTEF
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE SODIUM SUCCINATE | 100 mg/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 50LQB69S1Z |
| Rxcui | 238755 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51662-1261-1 | SOLU-CORTEF | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, FOR SOLUTION | 2 | | 6 |
| 51662-1261-2 | SOLU-CORTEF | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, FOR SOLUTION | 2 | | 6 |
| 51662-1261-2 | SOLU-CORTEF | 1 in 1 POUCH | INJECTION, POWDER, FOR SOLUTION | 1 | | 6 |
| 51662-1261-3 | SOLU-CORTEF | 25 in 1 CASE | INJECTION, POWDER, FOR SOLUTION | 25 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1261 | SOLU-CORTEF INJECTION, POWDER, FOR SOLUTION [HF ACQUISITION CO. LLC, DBA HEALTHFIRST] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240224_74f84173-a43f-7788-e053-2991aa0a8fb2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51662-1261-1 | 51662126101 | 2 mL in 1 VIAL, SINGLE-DOSE (51662-1261-1) | 2 ml | 2018-09-03 | 0000-00-00 | No | No | Current |
| 51662-1261-2 | 51662126102 | 2 mL in 1 VIAL, SINGLE-DOSE | 2 ml | | | | | Historical |
| 51662-1261-3 | 51662126103 | 25 POUCH in 1 CASE (51662-1261-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1261-2) / 2 mL in 1 VIAL, SINGLE-DOSE | 25 pouch | 2022-11-10 | 0000-00-00 | No | No | Current |