PredniSONE
- Product NDC
- 10544-093
- 11-digit product format
- 105440093
- Labeler code
- 10544
- Product ID
- 10544-093_116acf2b-e611-0e90-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PredniSONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA084122
- Marketing category
- ANDA
- Marketing start
- 2012-12-18
- Marketing end
- 0000-00-00
- Substance
- PREDNISONE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 10544-093-42 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a0ba-f424-e053-dadaa90a57ce | PredniSONE Tablets USP, 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, and 50 mg, PredniSONE Oral Solution USP, 5 mg per 5 mL and PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10544-093-42 | PredniSONE | 42 in 1 BOTTLE, PLASTIC | TABLET | 42 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PREDNISONE | ACTIVE INGREDIENT | VB0R961HZT | PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| PREDNISONE | ACTIVE MOIETY | VB0R961HZT | PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| SODIUM GLYCOLATE | INACTIVE INGREDIENT | B75E535IMI | PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-093 | PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 1 package rows | 20150316_116acf2b-e610-0e90-e054-00144ff88e88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-093-42 | 10544009342 | 42 in 1 BOTTLE, PLASTIC | Historical |