Hydrocortisone Valerate
- Product NDC
- 51672-1290
- 11-digit product format
- 516721290
- Labeler code
- 51672
- Product ID
- 51672-1290_39628349-b388-4030-e063-6394a90a6ce9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone Valerate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA075042
- Marketing category
- ANDA
- Marketing start
- 1998-08-25
- 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, 1370754 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51672-1290-1 | Hydrocortisone Valerate | 1 in 1 CARTON | CREAM | 1 | | 7 |
| 51672-1290-1 | Hydrocortisone Valerate | 15 g in 1 TUBE | CREAM | 15 | | 7 |
| 51672-1290-3 | Hydrocortisone Valerate | 1 in 1 CARTON | CREAM | 1 | | 7 |
| 51672-1290-3 | Hydrocortisone Valerate | 60 g in 1 TUBE | CREAM | 60 | | 7 |
| 51672-1290-6 | Hydrocortisone Valerate | 45 g in 1 TUBE | CREAM | 45 | | 7 |
| 51672-1290-6 | Hydrocortisone Valerate | 1 in 1 CARTON | CREAM | 1 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Hydrocortisone Valerate | ACTIVE INGREDIENT | 68717P8FUZ | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| Hydrocortisone | ACTIVE MOIETY | WI4X0X7BPJ | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| carbomer homopolymer type b (allyl pentaerythritol crosslinked) | INACTIVE INGREDIENT | HHT01ZNK31 | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| carbomer homopolymer type c (allyl pentaerythritol crosslinked) | INACTIVE INGREDIENT | 4Q93RCW27E | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| mineral oil | INACTIVE INGREDIENT | T5L8T28FGP | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| petrolatum | INACTIVE INGREDIENT | 4T6H12BN9U | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| sodium lauryl sulfate | INACTIVE INGREDIENT | 368GB5141J | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| sodium phosphate, dibasic | INACTIVE INGREDIENT | GR686LBA74 | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| steareth-100 | INACTIVE INGREDIENT | 4OH5W9UM87 | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| stearyl alcohol | INACTIVE INGREDIENT | 2KR89I4H1Y | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| HYDROCORTISONE VALERATE | ACTIVE INGREDIENT | 68717P8FUZ | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| Hydrocortisone Valerate | ACTIVE INGREDIENT | 68717P8FUZ | HYDROCORTISONE VALERATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| Hydrocortisone | ACTIVE MOIETY | WI4X0X7BPJ | HYDROCORTISONE VALERATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| CARBOMER HOMOPOLYMER TYPE B | INACTIVE INGREDIENT | HHT01ZNK31 | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CARBOMER HOMOPOLYMER TYPE C | INACTIVE INGREDIENT | 4Q93RCW27E | HYDROCORTISONE VALERATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| CARBOMER HOMOPOLYMER TYPE C | INACTIVE INGREDIENT | 4Q93RCW27E | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | HYDROCORTISONE VALERATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | HYDROCORTISONE VALERATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | HYDROCORTISONE VALERATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| sodium lauryl sulfate | INACTIVE INGREDIENT | 368GB5141J | HYDROCORTISONE VALERATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SODIUM PHOSPHATE, DIBASIC ANHYDROUS | INACTIVE INGREDIENT | 22ADO53M6F | HYDROCORTISONE VALERATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| STEARETH-100 | INACTIVE INGREDIENT | 4OH5W9UM87 | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| STEARETH-100 | INACTIVE INGREDIENT | 4OH5W9UM87 | HYDROCORTISONE VALERATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| STEARETH-2 | INACTIVE INGREDIENT | V56DFE46J5 | HYDROCORTISONE VALERATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| STEARETH-2 | INACTIVE INGREDIENT | V56DFE46J5 | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| stearyl alcohol | INACTIVE INGREDIENT | 2KR89I4H1Y | HYDROCORTISONE VALERATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | HYDROCORTISONE VALERATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51672-1290 | HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 6 | Current NDC, Legacy NDC, 6 package rows | 20230129_a9011d6f-6808-48a7-ab6b-df8d40540570.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 |
|---|
| 51672-1290-1 | 51672129001 | 1 TUBE in 1 CARTON (51672-1290-1) / 15 g in 1 TUBE | 1 tube | 1998-08-25 | 0000-00-00 | No | No | Current |
| 51672-1290-3 | 51672129003 | 1 TUBE in 1 CARTON (51672-1290-3) / 60 g in 1 TUBE | 1 tube | 1998-08-25 | 0000-00-00 | No | No | Current |
| 51672-1290-6 | 51672129006 | 1 TUBE in 1 CARTON (51672-1290-6) / 45 g in 1 TUBE | 1 tube | 1998-08-25 | 0000-00-00 | No | No | Current |