Hydrocortisone
- Product NDC
- 82804-084
- 11-digit product format
- 828040084
- Labeler code
- 82804
- Product ID
- 82804-084_848574fe-a23e-4e15-8c29-d624f50b71de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Proficient Rx LP
- Application
- ANDA085027
- Marketing category
- ANDA
- Marketing start
- 2006-06-13
- 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 | 103401 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-084-20 | Hydrocortisone | 1 in 1 CARTON | OINTMENT | 1 | | 1 |
| 82804-084-20 | Hydrocortisone | 20 g in 1 TUBE | OINTMENT | 20 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-084 | HYDROCORTISONE OINTMENT [PROFICIENT RX LP] | 1 | Current NDC, 2 package rows | 20240327_848574fe-a23e-4e15-8c29-d624f50b71de.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 |
|---|
| 82804-084-20 | 82804008420 | 1 TUBE in 1 CARTON (82804-084-20) / 20 g in 1 TUBE | 1 tube | 2024-03-19 | No | No | Historical |