prednisone
- Product NDC
- 64380-783
- 11-digit product format
- 643800783
- Labeler code
- 64380
- Product ID
- 64380-783_c389b525-c68a-43dc-bacc-c75707b391b5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREDNISONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA208412
- Marketing category
- ANDA
- Marketing start
- 2021-09-01
- Substance
- PREDNISONE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VB0R961HZT |
| Rxcui | 198146, 312617 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64380-783-01 | prednisone | 10 in 1 BLISTER PACK | TABLET | 10 | | 10 |
| 64380-783-01 | prednisone | 10 in 1 CARTON | TABLET | 10 | | 10 |
| 64380-783-06 | prednisone | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 10 |
| 64380-783-08 | prednisone | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-783 | PREDNISONE TABLET [STRIDES PHARMA SCIENCE LIMITED] | 9 | Current NDC, Legacy NDC, 4 package rows | 20250116_52010a34-aadb-4561-ac4a-3ee53f5e3566.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 |
|---|
| 64380-783-01 | 64380078301 | 10 BLISTER PACK in 1 CARTON (64380-783-01) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2021-09-01 | 0000-00-00 | No | No | Current |
| 64380-783-06 | 64380078306 | 100 TABLET in 1 BOTTLE, PLASTIC (64380-783-06) | 100 tablet | 2021-09-01 | 0000-00-00 | No | No | Current |
| 64380-783-08 | 64380078308 | 1000 TABLET in 1 BOTTLE, PLASTIC (64380-783-08) | 1000 tablet | 2021-09-01 | 0000-00-00 | No | No | Current |