PredniSONE
- Product NDC
- 68071-2509
- 11-digit product format
- 680712509
- Labeler code
- 68071
- Product ID
- 68071-2509_ca3e5eab-588b-998d-e053-2a95a90aa6f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PredniSONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA080352
- Marketing category
- ANDA
- Marketing start
- 2020-03-23
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-2509-1 | 2026-01-23 | C162847 | 48780-1 | f386c649-d182-0266-e053-dadaa90a7c1a | PredniSONE Tablets, USP |
| 68071-2509-2 | 2026-01-23 | C162847 | 48780-1 | f386c649-d182-0266-e053-dadaa90a7c1a | PredniSONE Tablets, USP |
| 68071-2509-3 | 2026-01-23 | C162847 | 48780-1 | f386c649-d182-0266-e053-dadaa90a7c1a | PredniSONE Tablets, USP |
| 68071-2509-5 | 2026-01-23 | C162847 | 48780-1 | f386c649-d182-0266-e053-dadaa90a7c1a | PredniSONE Tablets, USP |
| 68071-2509-6 | 2026-01-23 | C162847 | 48780-1 | f386c649-d182-0266-e053-dadaa90a7c1a | PredniSONE Tablets, USP |
| 68071-2509-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-d182-0266-e053-dadaa90a7c1a | PredniSONE Tablets, USP |
| 68071-2509-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-d182-0266-e053-dadaa90a7c1a | PredniSONE Tablets, USP |
| 68071-2509-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-d182-0266-e053-dadaa90a7c1a | PredniSONE Tablets, USP |
| 68071-2509-5 | 2023-01-30 | C162847 | 48780-1 | f386c649-d182-0266-e053-dadaa90a7c1a | PredniSONE Tablets, USP |
| 68071-2509-6 | 2023-01-30 | C162847 | 48780-1 | f386c649-d182-0266-e053-dadaa90a7c1a | PredniSONE Tablets, USP |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-2509 | PREDNISONE TABLET [NUCARE PHARMACEUTICALS,INC.] | 1 | Legacy NDC | 20210825_ca3e5394-ed5b-45a3-e053-2995a90ac0f3.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-2509-1 | 68071250901 | 21 TABLET in 1 BOTTLE (68071-2509-1) | 21 tablet | 2021-08-23 | 0000-00-00 | No | No | Current |
| 68071-2509-2 | 68071250902 | 20 TABLET in 1 BOTTLE (68071-2509-2) | 20 tablet | 2021-08-23 | 0000-00-00 | No | No | Current |
| 68071-2509-3 | 68071250903 | 30 TABLET in 1 BOTTLE (68071-2509-3) | 30 tablet | 2021-08-23 | 0000-00-00 | No | No | Current |
| 68071-2509-5 | 68071250905 | 15 TABLET in 1 BOTTLE (68071-2509-5) | 15 tablet | 2021-08-23 | 0000-00-00 | No | No | Current |
| 68071-2509-6 | 68071250906 | 60 TABLET in 1 BOTTLE (68071-2509-6) | 60 tablet | 2021-08-23 | 0000-00-00 | No | No | Current |