Hydrocortisone Valerate
- Product NDC
- 0713-0560
- 11-digit product format
- 007130560
- Labeler code
- 0713
- Product ID
- 0713-0560_0b46d11e-449c-315b-e063-6294a90a6e2a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCORTISONE VALERATE
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- ANDA211764
- Marketing category
- ANDA
- Marketing start
- 2021-05-03
- Substance
- HYDROCORTISONE VALERATE
- Active strength
- 2 mg/g
- 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
- Hydrocortisone Valerate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE VALERATE | 2 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 68717P8FUZ |
| Rxcui | 1370750 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0713-0560-15 | Hydrocortisone Valerate | 1 in 1 CARTON | OINTMENT | 1 | | 4 |
| 0713-0560-15 | Hydrocortisone Valerate | 15 g in 1 TUBE | OINTMENT | 15 | | 4 |
| 0713-0560-37 | Hydrocortisone Valerate | 45 g in 1 TUBE | OINTMENT | 45 | | 4 |
| 0713-0560-37 | Hydrocortisone Valerate | 1 in 1 CARTON | OINTMENT | 1 | | 4 |
| 0713-0560-60 | Hydrocortisone Valerate | 60 g in 1 TUBE | OINTMENT | 60 | | 4 |
| 0713-0560-60 | Hydrocortisone Valerate | 1 in 1 CARTON | OINTMENT | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0713-0560 | HYDROCORTISONE VALERATE OINTMENT [COSETTE PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 6 package rows | 20231130_1cb06573-1ac8-4dfe-8123-00bbd20a1650.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 |
|---|
| 0713-0560-15 | 00713056015 | 1 TUBE in 1 CARTON (0713-0560-15) / 15 g in 1 TUBE | 1 tube | 2021-05-03 | 0000-00-00 | No | No | Current |
| 0713-0560-37 | 00713056037 | 1 TUBE in 1 CARTON (0713-0560-37) / 45 g in 1 TUBE | 1 tube | 2021-05-03 | 0000-00-00 | No | No | Current |
| 0713-0560-60 | 00713056060 | 1 TUBE in 1 CARTON (0713-0560-60) / 60 g in 1 TUBE | 1 tube | 2021-05-03 | 0000-00-00 | No | No | Current |