Prednisone
- Product NDC
- 10135-776
- 11-digit product format
- 101350776
- Labeler code
- 10135
- Product ID
- 10135-776_441fcae7-8682-1a29-e063-6394a90a3881
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prednisone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals, Inc.
- Application
- ANDA211575
- Marketing category
- ANDA
- Marketing start
- 2023-02-01
- 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
- 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, 198146, 198148, 312615, 312617 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10135-776-01 | Prednisone | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 10135-776-10 | Prednisone | 1000 in 1 BOTTLE | TABLET | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-776 | PREDNISONE TABLET [MARLEX PHARMACEUTICALS, INC.] | 2 | Current NDC, 2 package rows | 20241018_f499197b-b9b7-1707-e053-2a95a90a0932.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 |
|---|
| 10135-776-01 | 10135077601 | 100 TABLET in 1 BOTTLE (10135-776-01) | 100 tablet | 2023-02-01 | No | No | Current |
| 10135-776-10 | 10135077610 | 1000 TABLET in 1 BOTTLE (10135-776-10) | 1000 tablet | 2023-02-01 | No | No | Current |