PredniSONE
- Product NDC
- 66336-058
- 11-digit product format
- 663360058
- Labeler code
- 66336
- Product ID
- 66336-058_5806e4cf-77b1-4d57-8ce8-ef11dc30144c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PredniSONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dispensing Solutions, Inc.
- Application
- ANDA084122
- Marketing category
- ANDA
- Marketing start
- 2003-02-13
- 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 |
|---|
| 66336-058-15 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-882d-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 |
| 66336-058-90 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e1b9-cd31-e053-dbdaa90ab51a | PredniSONE Tablets USP, 1 mg, 10 mg |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66336-058-90 | PredniSONE | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 3 |
| 66336-058-15 | PredniSONE | 15 in 1 BOTTLE | TABLET | 15 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PREDNISONE | ACTIVE INGREDIENT | VB0R961HZT | PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] | 3 | |
| PREDNISONE | ACTIVE MOIETY | VB0R961HZT | PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] | 3 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] | 3 | |
| PREDNISONE | ACTIVE INGREDIENT | VB0R961HZT | PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] | 2 | |
| PREDNISONE | ACTIVE MOIETY | VB0R961HZT | PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] | 2 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66336-058 | PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] | 3 | Legacy NDC, 1 package rows | 20130409_ee0621e8-fecd-4b9e-9e1b-91a4abf22bdb.zip |
| 66336-058 | PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] | 2 | Legacy NDC, 1 package rows | 20120929_e23a0f1e-e8ff-4be2-a74f-bc54cd44b3db.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 66336-058-15 | 66336005815 | 15 in 1 BOTTLE | Historical |
| 66336-058-90 | 66336005890 | 90 in 1 BOTTLE, PLASTIC | Historical |