HYDROCORTISONE VALERATE
- Product NDC
- 68180-954
- 11-digit product format
- 681800954
- Labeler code
- 68180
- Product ID
- 68180-954_a6615fbc-add1-481b-98e0-afd117c7a599
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCORTISONE VALERATE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA210307
- Marketing category
- ANDA
- Marketing start
- 2019-11-19
- Substance
- HYDROCORTISONE VALERATE
- Active strength
- 2 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HYDROCORTISONE VALERATE
- Listing expiration
- 2027-12-31
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 |
|---|
| 68180-954-01 | HYDROCORTISONE VALERATE | 15 g in 1 TUBE | CREAM | 15 | | 7 |
| 68180-954-01 | HYDROCORTISONE VALERATE | 1 in 1 CARTON | CREAM | 1 | | 7 |
| 68180-954-02 | HYDROCORTISONE VALERATE | 45 g in 1 TUBE | CREAM | 45 | | 7 |
| 68180-954-02 | HYDROCORTISONE VALERATE | 1 in 1 CARTON | CREAM | 1 | | 7 |
| 68180-954-03 | HYDROCORTISONE VALERATE | 60 g in 1 TUBE | CREAM | 60 | | 7 |
| 68180-954-03 | HYDROCORTISONE VALERATE | 1 in 1 CARTON | CREAM | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-954 | HYDROCORTISONE VALERATE CREAM [LUPIN PHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 6 package rows | 20250322_17e93b8c-aede-4cab-9a8c-0c29abdb05f2.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 |
|---|
| 68180-954-01 | 68180095401 | 1 TUBE in 1 CARTON (68180-954-01) / 15 g in 1 TUBE | 1 tube | 2019-11-19 | 0000-00-00 | No | No | Current |
| 68180-954-02 | 68180095402 | 1 TUBE in 1 CARTON (68180-954-02) / 45 g in 1 TUBE | 1 tube | 2019-11-19 | 0000-00-00 | No | No | Current |
| 68180-954-03 | 68180095403 | 1 TUBE in 1 CARTON (68180-954-03) / 60 g in 1 TUBE | 1 tube | 2019-11-19 | 0000-00-00 | No | No | Current |