Hydrocortisone Butyrate
- Product NDC
- 51672-4083
- 11-digit product format
- 516724083
- Labeler code
- 51672
- Product ID
- 51672-4083_26e4c766-6315-4c55-9814-181258a45ad5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone Butyrate
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Taro Pharmaceuticals U.S.A., Inc.
- Application
- ANDA076842
- Marketing category
- ANDA
- Marketing start
- 2004-12-27
- Substance
- HYDROCORTISONE BUTYRATE
- Active strength
- 1 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 Butyrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE BUTYRATE | 1 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 05RMF7YPWN |
| Rxcui | 1370758, 1370767, 1370770 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51672-4083-1 | Hydrocortisone Butyrate | 15 g in 1 TUBE | OINTMENT | 15 | | 5 |
| 51672-4083-1 | Hydrocortisone Butyrate | 1 in 1 CARTON | OINTMENT | 1 | | 5 |
| 51672-4083-2 | Hydrocortisone Butyrate | 1 in 1 CARTON | OINTMENT | 1 | | 5 |
| 51672-4083-2 | Hydrocortisone Butyrate | 30 g in 1 TUBE | OINTMENT | 30 | | 5 |
| 51672-4083-5 | Hydrocortisone Butyrate | 5 g in 1 TUBE | OINTMENT | 5 | | 5 |
| 51672-4083-6 | Hydrocortisone Butyrate | 45 g in 1 TUBE | OINTMENT | 45 | | 5 |
| 51672-4083-6 | Hydrocortisone Butyrate | 1 in 1 CARTON | OINTMENT | 1 | | 5 |
| 51672-4083-7 | Hydrocortisone Butyrate | 1 in 1 CARTON | OINTMENT | 1 | | 5 |
| 51672-4083-7 | Hydrocortisone Butyrate | 10 g in 1 TUBE | OINTMENT | 10 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Hydrocortisone Butyrate | ACTIVE INGREDIENT | 05RMF7YPWN | HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| Hydrocortisone | ACTIVE MOIETY | WI4X0X7BPJ | HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| anhydrous citric acid | INACTIVE INGREDIENT | XF417D3PSL | HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| anhydrous trisodium citrate | INACTIVE INGREDIENT | RS7A450LGA | HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| butylparaben | INACTIVE INGREDIENT | 3QPI1U3FV8 | HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| ceteth-20 | INACTIVE INGREDIENT | I835H2IHHX | HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| cetostearyl alcohol | INACTIVE INGREDIENT | 2DMT128M1S | HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| citric acid monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| high density polyethylene | INACTIVE INGREDIENT | UG00KM4WR7 | HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| isopropyl alcohol | INACTIVE INGREDIENT | ND2M416302 | HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| light mineral oil | INACTIVE INGREDIENT | N6K5787QVP | HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| mineral oil | INACTIVE INGREDIENT | T5L8T28FGP | HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| petrolatum | INACTIVE INGREDIENT | 4T6H12BN9U | HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| povidones | INACTIVE INGREDIENT | FZ989GH94E | HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| trisodium citrate dihydrate | INACTIVE INGREDIENT | B22547B95K | HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51672-4083 | HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] | 5 | Current NDC, Legacy NDC, 9 package rows | 20210409_51176835-598d-4da7-8a00-6bd36f52aa82.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 |
|---|
| 51672-4083-1 | 51672408301 | 1 TUBE in 1 CARTON (51672-4083-1) / 15 g in 1 TUBE | 1 tube | 2004-12-27 | 0000-00-00 | No | No | Current |
| 51672-4083-2 | 51672408302 | 1 TUBE in 1 CARTON (51672-4083-2) / 30 g in 1 TUBE | 1 tube | 2004-12-27 | 0000-00-00 | No | No | Current |
| 51672-4083-5 | 51672408305 | 5 g in 1 TUBE (51672-4083-5) | 5 g | 2004-12-27 | 0000-00-00 | No | No | Current |
| 51672-4083-6 | 51672408306 | 1 TUBE in 1 CARTON (51672-4083-6) / 45 g in 1 TUBE | 1 tube | 2004-12-27 | 0000-00-00 | No | No | Current |
| 51672-4083-7 | 51672408307 | 1 TUBE in 1 CARTON (51672-4083-7) / 10 g in 1 TUBE | 1 tube | 2004-12-27 | 0000-00-00 | No | No | Current |