Prednisone
- Product NDC
- 0603-5335
- 11-digit product format
- 006035335
- Labeler code
- 0603
- Product ID
- 0603-5335_e6628b5c-a3e4-462b-a01a-695ed8d3ab64
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prednisone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Endo USA, Inc.
- Application
- ANDA040584
- Marketing category
- ANDA
- Marketing start
- 2004-12-21
- Substance
- PREDNISONE
- Active strength
- 1 mg/1
- 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
- Prednisone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PREDNISONE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VB0R961HZT |
| Rxcui | 198144, 198145, 198146, 312615, 312617, 763179, 763181, 763183, 763185 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 0603-5335-21 | 2022-08-19 | C162847 | 48780-1 | e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e | PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only |
| 0603-5335-21 | 2022-08-19 | C162847 | 48780-1 | e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e | PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only |
| 0603-5335-32 | 2022-08-19 | C162847 | 48780-1 | e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e | PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only |
| 0603-5335-32 | 2022-08-19 | C162847 | 48780-1 | e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e | PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only |
| 0603-5335-21 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e | PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only |
| 0603-5335-21 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e | PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only |
| 0603-5335-32 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e | PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only |
| 0603-5335-32 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-9b63-d8a0-e053-dadaa90a6e4e | PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0603-5335-21 | Prednisone | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 32 |
| 0603-5335-32 | Prednisone | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 32 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0603-5335 | PREDNISONE TABLET [ENDO USA, INC.] | 32 | Current NDC, Legacy NDC, 2 package rows | 20240927_10fe5a3b-84dc-4600-87c2-b80c97ce18cf.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 |
|---|
| 0603-5335-21 | 00603533521 | 100 TABLET in 1 BOTTLE, PLASTIC (0603-5335-21) | 100 tablet | 2004-12-21 | 0000-00-00 | No | No | Current |
| 0603-5335-32 | 00603533532 | 1000 TABLET in 1 BOTTLE, PLASTIC (0603-5335-32) | 1000 tablet | 2004-12-21 | 0000-00-00 | No | No | Current |