pravastatin sodium
- Product NDC
- 43063-443
- 11-digit product format
- 430630443
- Labeler code
- 43063
- Product ID
- 43063-443_e6885ab6-0e1a-6610-e053-2995a90acbcc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pravastatin sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA077751
- Marketing category
- ANDA
- Marketing start
- 2010-03-30
- Marketing end
- 0000-00-00
- Substance
- PRAVASTATIN SODIUM
- Active strength
- 20 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PRAVASTATIN SODIUM | ACTIVE INGREDIENT | 3M8608UQ61 | PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| PRAVASTATIN | ACTIVE MOIETY | KXO2KT9N0G | PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| POLYOXYL 35 CASTOR OIL | INACTIVE INGREDIENT | 6D4M1DAL6O | PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-443 | PRAVASTATIN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.] | 18 | Legacy NDC | 20241012_08f16c8a-0602-4537-b935-3de29e3d8a79.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-443-30 | 43063044330 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-443-30) | 30 tablet | 2012-10-22 | 0000-00-00 | No | No | Current |
| 43063-443-90 | 43063044390 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-443-90) | 90 tablet | 2012-10-22 | 0000-00-00 | No | No | Current |