Pravastatin Sodium
- Product NDC
- 43353-927
- 11-digit product format
- 433530927
- Labeler code
- 43353
- Product ID
- 43353-927_6363687c-dcff-451f-8a81-d9f04e79f9ad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pravastatin Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA076056
- Marketing category
- ANDA
- Marketing start
- 2006-04-25
- Marketing end
- 0000-00-00
- Substance
- PRAVASTATIN SODIUM
- Active strength
- 40 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-927-45 | Pravastatin Sodium | 45 in 1 BOTTLE, PLASTIC | TABLET | 45 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PRAVASTATIN SODIUM | ACTIVE INGREDIENT | 3M8608UQ61 | PRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| PRAVASTATIN | ACTIVE MOIETY | KXO2KT9N0G | PRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | PRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | PRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | PRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | PRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | PRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | PRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | PRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | PRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | PRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-927 | PRAVASTATIN SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Legacy NDC, 1 package rows | 20140516_ca845bb6-8047-40ae-8d39-26879c4ef2ab.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 43353-927-45 | 43353092745 | 45 in 1 BOTTLE, PLASTIC | Historical |