Hydrocortisone
- Product NDC
- 70518-3078
- 11-digit product format
- 705183078
- Labeler code
- 70518
- Product ID
- 70518-3078_4e912730-4dd7-aa1f-e063-6394a90aed47
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA085025
- Marketing category
- ANDA
- Marketing start
- 2021-04-22
- Substance
- HYDROCORTISONE
- Active strength
- 25 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrocortisone
- Listing expiration
- 2027-12-31
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 |
|---|
| 70518-3078-0 | Hydrocortisone | 1 in 1 CARTON | CREAM | 1 | | 11 |
| 70518-3078-0 | Hydrocortisone | 20 g in 1 TUBE | CREAM | 20 | | 11 |
| 70518-3078-1 | Hydrocortisone | 1 in 1 CARTON | CREAM | 1 | | 11 |
| 70518-3078-1 | Hydrocortisone | 28 g in 1 TUBE | CREAM | 28 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3078 | HYDROCORTISONE CREAM [REMEDYREPACK INC.] | 8 | Current NDC, Legacy NDC, 4 package rows | 20250116_f0e66726-946b-4f63-b457-2851dc69e6b4.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 |
|---|
| 70518-3078-0 | 70518307800 | 1 TUBE in 1 CARTON (70518-3078-0) / 20 g in 1 TUBE | 1 tube | 2021-04-22 | 0000-00-00 | No | No | Current |
| 70518-3078-1 | 70518307801 | 1 in 1 CARTON | | | | | | Historical |