Anusol
- Product NDC
- 65649-401
- 11-digit product format
- 656490401
- Labeler code
- 65649
- Product ID
- 65649-401_1103c6ea-1e5c-465c-bae8-9d56dfa9a7cd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocortisone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Salix Pharmaceuticals, Inc
- Application
- ANDA088250
- Marketing category
- ANDA
- Marketing start
- 1984-06-06
- Substance
- HYDROCORTISONE
- Active strength
- 25 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
- Anusol
- Brand name suffix
- HC
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE | 25 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WI4X0X7BPJ |
| Rxcui | 310891, 1659445 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65649-401-30 | AnusolHC | 30 g in 1 TUBE | CREAM | 30 | | 9 |
| 65649-401-30 | AnusolHC | 1 in 1 CARTON | CREAM | 1 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROCORTISONE | ACTIVE INGREDIENT | WI4X0X7BPJ | ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] | 3 | |
| HYDROCORTISONE | ACTIVE MOIETY | WI4X0X7BPJ | ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] | 3 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] | 3 | |
| CARBOMER 934 | INACTIVE INGREDIENT | Z135WT9208 | ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] | 3 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] | 3 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] | 3 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] | 3 | |
| POLYOXYL 40 STEARATE | INACTIVE INGREDIENT | 13A4J4NH9I | ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] | 3 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] | 3 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65649-401 | ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20230929_5a0439c8-50a0-4f85-9cb4-9e3a5b0c31e7.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 |
|---|
| 65649-401-30 | 65649040130 | 1 TUBE in 1 CARTON (65649-401-30) / 30 g in 1 TUBE | 1 tube | 1984-06-06 | 0000-00-00 | No | No | Current |