Prednisone
- Product NDC
- 53002-0610
- 11-digit product format
- 530020610
- Labeler code
- 53002
- Product ID
- 53002-0610_6aad77e0-e9b2-4012-bd0f-615fc0c4fe15
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prednisone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA040256
- Marketing category
- ANDA
- Marketing start
- 2002-07-12
- Marketing end
- 0000-00-00
- Substance
- PREDNISONE
- Active strength
- 5 mg/1
- 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 |
|---|
| 53002-0610-1 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-c6ee-f424-e053-dadaa90a57ce | PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg |
| 53002-0610-1 | 2023-06-08 | C162847 | 48780-1 | 9d75b9d0-c6ee-f424-e053-dadaa90a57ce | PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg |
| 53002-0610-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-c6ee-f424-e053-dadaa90a57ce | PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg |
| 53002-0610-1 | 2020-12-16 | C162847 | 48780-1 | 9d75b9d0-c6ee-f424-e053-dadaa90a57ce | PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg |
| 53002-0610-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c6ee-f424-e053-dadaa90a57ce | PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-0610-1 | Prednisone | 21 in 1 BOX, UNIT-DOSE | TABLET | 21 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-0610 | PREDNISONE TABLET [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20230609_78b919b1-5435-46ae-896c-19780343ebff.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 |
|---|
| 53002-0610-1 | 53002061001 | 21 TABLET in 1 BOX, UNIT-DOSE (53002-0610-1) | 21 tablet | 2017-10-01 | 0000-00-00 | No | No | Current |