PredniSONE Tablets, USP, 5 mg
- Product NDC
- 63561-0120
- 11-digit product format
- 635610120
- Labeler code
- 63561
- Product ID
- 63561-0120_3c696af0-7946-dd78-e063-6394a90a71cc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PredniSONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Granulation Technology, Inc.
- Application
- ANDA212629
- Marketing category
- ANDA
- Marketing start
- 2025-05-22
- Substance
- PREDNISONE
- Active strength
- 5 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 Tablets, USP, 5 mg
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PREDNISONE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VB0R961HZT |
| Rxcui | 198145, 312615, 312617 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63561-0120-1 | PredniSONE Tablets, USP, 5 mg | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 63561-0120-2 | PredniSONE Tablets, USP, 5 mg | 1000 in 1 BOTTLE | TABLET | 1000 | | 3 |
| 63561-0120-5 | PredniSONE Tablets, USP, 5 mg | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63561-0120 | PREDNISONE TABLETS, USP, 5 MG (PREDNISONE) TABLET PREDNISONE TABLETS, USP, 10 MG (PREDNISONE) TABLET PREDNISONE TABLETS, USP, 20 MG (PREDNISONE) TABLET [GRANULATION TECHNOLOGY, INC.] | 2 | Current NDC, 3 package rows | 20250524_a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 63561-0120-1 | 63561012001 | 100 TABLET in 1 BOTTLE (63561-0120-1) | 100 tablet | 2025-05-22 | No | No | Historical |
| 63561-0120-2 | 63561012002 | 1000 TABLET in 1 BOTTLE (63561-0120-2) | 1000 tablet | 2025-05-22 | No | No | Historical |
| 63561-0120-5 | 63561012005 | 500 TABLET in 1 BOTTLE (63561-0120-5) | 500 tablet | 2025-05-22 | No | No | Historical |