hydrocortisone valerate cream
- Product NDC
- 21922-007
- 11-digit product format
- 219220007
- Labeler code
- 21922
- Product ID
- 21922-007_85b1a924-1037-419a-a141-878a1539f013
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocortisone valerate cream
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Encube Ethicals, Inc.
- Application
- ANDA211047
- Marketing category
- ANDA
- Marketing start
- 2022-12-31
- 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 cream
- 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 |
|---|
| 21922-007-04 | hydrocortisone valerate cream | 15 g in 1 TUBE | CREAM | 15 | | 6 |
| 21922-007-04 | hydrocortisone valerate cream | 1 in 1 CARTON | CREAM | 1 | | 6 |
| 21922-007-06 | hydrocortisone valerate cream | 45 g in 1 TUBE | CREAM | 45 | | 6 |
| 21922-007-06 | hydrocortisone valerate cream | 1 in 1 CARTON | CREAM | 1 | | 6 |
| 21922-007-07 | hydrocortisone valerate cream | 60 g in 1 TUBE | CREAM | 60 | | 6 |
| 21922-007-07 | hydrocortisone valerate cream | 1 in 1 CARTON | CREAM | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21922-007 | HYDROCORTISONE VALERATE CREAM CREAM [ENCUBE ETHICALS PRIVATE LIMITED] | 5 | Current NDC, Legacy NDC, 6 package rows | 20241226_41723504-b2cf-4074-9c3a-e3c59bb48c98.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 |
|---|
| 21922-007-04 | 21922000704 | 1 TUBE in 1 CARTON (21922-007-04) / 15 g in 1 TUBE | 1 tube | 2022-12-31 | 0000-00-00 | No | No | Current |
| 21922-007-06 | 21922000706 | 1 TUBE in 1 CARTON (21922-007-06) / 45 g in 1 TUBE | 1 tube | 2022-12-31 | 0000-00-00 | No | No | Current |
| 21922-007-07 | 21922000707 | 1 TUBE in 1 CARTON (21922-007-07) / 60 g in 1 TUBE | 1 tube | 2022-12-31 | 0000-00-00 | No | No | Current |