Hydrocortisone Acetate Cream
- Product NDC
- 71297-241
- 11-digit product format
- 712970241
- Labeler code
- 71297
- Product ID
- 71297-241_3b007d65-4f52-825f-e063-6294a90a71bb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone Acetate Cream
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Allegis Holdings LLC
- Application
- ANDA040396
- Marketing category
- ANDA
- Marketing start
- 2025-07-28
- Substance
- HYDROCORTISONE ACETATE
- Active strength
- 20 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 Acetate Cream
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE ACETATE | 20 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3X7931PO74 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71297-241-01 | Hydrocortisone Acetate Cream | 28.4 g in 1 CARTON | CREAM | 28.4 | | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71297-241-01 | 71297024101 | 28.4 g in 1 CARTON (71297-241-01) | 28.4 g | 2025-07-28 | No | No | Current |