Hydrocortisone
- Product NDC
- 53002-8780
- 11-digit product format
- 530028780
- Labeler code
- 53002
- Product ID
- 53002-8780_71818e00-5115-4877-87dd-a9e9c96d0c06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocortisone
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA081203
- Marketing category
- ANDA
- Marketing start
- 1993-05-28
- Marketing end
- 0000-00-00
- Substance
- HYDROCORTISONE
- Active strength
- 25 mg/g
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-8780-2 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-0ccd-f424-e053-dadaa90a57ce | HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5% |
| 53002-8780-2 | 2023-06-08 | C162847 | 48780-1 | 9d75b9d0-0ccd-f424-e053-dadaa90a57ce | HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5% |
| 53002-8780-2 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-0ccd-f424-e053-dadaa90a57ce | HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5% |
| 53002-8780-2 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d0-0ccd-f424-e053-dadaa90a57ce | HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5% |
| 53002-8780-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-0ccd-f424-e053-dadaa90a57ce | HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5% |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-8780-2 | Hydrocortisone | 30 g in 1 TUBE | OINTMENT | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-8780 | HYDROCORTISONE OINTMENT [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20230609_4e4b7175-2046-4bfe-aee3-afafe08300f3.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 |
|---|
| 53002-8780-2 | 53002878002 | 30 g in 1 TUBE (53002-8780-2) | 30 g | 2018-10-01 | 0000-00-00 | No | No | Current |