Hydrocortisone
- Product NDC
- 62559-430
- 11-digit product format
- 625590430
- Labeler code
- 62559
- Product ID
- 62559-430_4538e1ca-670f-4800-ae86-1a728e6b029b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA080706
- Marketing category
- ANDA
- Marketing start
- 2016-04-01
- Substance
- HYDROCORTISONE
- Active strength
- 10 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WI4X0X7BPJ |
| Rxcui | 106258, 310891 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62559-430-01 | Hydrocortisone | 1 in 1 CARTON | CREAM | 1 | | 4 |
| 62559-430-01 | Hydrocortisone | 28.4 g in 1 TUBE | CREAM | 28.4 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62559-430 | HYDROCORTISONE CREAM [ANI PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20181220_b2918ac7-14b5-4372-9055-8caf6f4bcf37.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 |
|---|
| 62559-430-01 | 62559043001 | 1 TUBE in 1 CARTON (62559-430-01) / 28.4 g in 1 TUBE | 1 tube | 2016-04-01 | 0000-00-00 | No | No | Current |