Hydrocortisone
- Product NDC
- 53002-8350
- 11-digit product format
- 530028350
- Labeler code
- 53002
- Product ID
- 53002-8350_d13c5618-cd91-45b4-8c37-9763a01e772d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA080692
- Marketing category
- ANDA
- Marketing start
- 1975-04-16
- Marketing end
- 0000-00-00
- Substance
- HYDROCORTISONE
- Active strength
- 10 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-8350-1 | Hydrocortisone | 30 g in 1 TUBE | OINTMENT | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-8350 | HYDROCORTISONE OINTMENT [RPK PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 1 package rows | 20220331_39aa6953-9e27-4136-ab4a-e30db49ee81b.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 |
|---|
| 53002-8350-1 | 53002835001 | 30 g in 1 TUBE (53002-8350-1) | 30 g | 2022-06-01 | 0000-00-00 | No | No | Current |