HYDROCORTISONE VALERATE
- Product NDC
- 0713-0720
- 11-digit product format
- 007130720
- Labeler code
- 0713
- Product ID
- 0713-0720_0b469afc-621e-133a-e063-6294a90a6344
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCORTISONE VALERATE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- ANDA213724
- Marketing category
- ANDA
- Marketing start
- 2021-07-01
- 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 | 1370754 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0713-0720-15 | HYDROCORTISONE VALERATE | 1 in 1 CARTON | CREAM | 1 | | 2 |
| 0713-0720-15 | HYDROCORTISONE VALERATE | 15 g in 1 TUBE | CREAM | 15 | | 2 |
| 0713-0720-37 | HYDROCORTISONE VALERATE | 45 g in 1 TUBE | CREAM | 45 | | 2 |
| 0713-0720-37 | HYDROCORTISONE VALERATE | 1 in 1 CARTON | CREAM | 1 | | 2 |
| 0713-0720-60 | HYDROCORTISONE VALERATE | 60 g in 1 TUBE | CREAM | 60 | | 2 |
| 0713-0720-60 | HYDROCORTISONE VALERATE | 1 in 1 CARTON | CREAM | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0713-0720 | HYDROCORTISONE VALERATE CREAM [COSETTE PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 6 package rows | 20231130_fd68f7a2-fa0d-4d56-8e92-71cd955cc7a9.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 |
|---|
| 0713-0720-15 | 00713072015 | 1 TUBE in 1 CARTON (0713-0720-15) / 15 g in 1 TUBE | 1 tube | 2021-07-01 | 0000-00-00 | No | No | Current |
| 0713-0720-37 | 00713072037 | 1 TUBE in 1 CARTON (0713-0720-37) / 45 g in 1 TUBE | 1 tube | 2021-07-01 | 0000-00-00 | No | No | Current |
| 0713-0720-60 | 00713072060 | 1 TUBE in 1 CARTON (0713-0720-60) / 60 g in 1 TUBE | 1 tube | 2021-07-01 | 0000-00-00 | No | No | Current |