Hydrocortisone
- Product NDC
- 82804-135
- 11-digit product format
- 828040135
- Labeler code
- 82804
- Product ID
- 82804-135_e1166b3a-a304-4030-ab51-eb55c6e91afd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Proficient Rx LP
- Application
- ANDA085025
- Marketing category
- ANDA
- Marketing start
- 2006-03-31
- 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
- Hydrocortisone
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-135-28 | Hydrocortisone | 28 g in 1 TUBE | CREAM | 28 | | 1 |
| 82804-135-28 | Hydrocortisone | 1 in 1 CARTON | CREAM | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-135 | HYDROCORTISONE CREAM [PROFICIENT RX LP] | 1 | Current NDC, 2 package rows | 20240824_e1166b3a-a304-4030-ab51-eb55c6e91afd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-135-28 | 82804013528 | 1 TUBE in 1 CARTON (82804-135-28) / 28 g in 1 TUBE | 1 tube | 2024-08-22 | No | No | Current |