Prednisone
- Product NDC
- 33261-780
- 11-digit product format
- 332610780
- Labeler code
- 33261
- Product ID
- 33261-780_3eb42c9e-ade5-41e9-8fb2-32551a571d28
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prednisone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA040256
- Marketing category
- ANDA
- Marketing start
- 2002-07-12
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 2205d503-be51-445b-bb34-c209cc557b3c | Product name | 5 | 20230105 |
| 9492a99d-61c8-491f-9086-1c6a7e98c040 | Product name | 6 | 20230105 |
| 205c2cdd-a63b-cbc9-6bcb-6be6001edf81 | Product name | 2 | 20170705 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 33261-780-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d2c7-f424-e053-dadaa90a57ce | PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33261-780-01 | Prednisone | 21 in 1 BOX, UNIT-DOSE | TABLET | 21 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 33261-780-01 | EA - Each | 33261-780 | 21ea4d83-bfa9-4184-9ed9-6ab3b72d9052 | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PREDNISONE | ACTIVE INGREDIENT | VB0R961HZT | PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| PREDNISONE | ACTIVE MOIETY | VB0R961HZT | PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 763181 | {21 (prednisone 5 MG Oral Tablet) } Pack | GPCK | 70571f29-168e-477a-85c2-b366aebf2b40 | 1 |
| 312617 | predniSONE 5 MG Oral Tablet | PSN | 70571f29-168e-477a-85c2-b366aebf2b40 | 1 |
| 763181 | predniSONE 5 MG Tablet 21 Count Pack | PSN | 70571f29-168e-477a-85c2-b366aebf2b40 | 1 |
| 312617 | prednisone 5 MG Oral Tablet | SCD | 70571f29-168e-477a-85c2-b366aebf2b40 | 1 |
| 763181 | Prednisone 5 MG Oral Tablet 21 Count Pack | SY | 70571f29-168e-477a-85c2-b366aebf2b40 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 33261-780-01 | 33261078001 | 21 in 1 BOX, UNIT-DOSE | Historical |