PRAVASTATIN SODIUM
- Product NDC
- 67046-1519
- 11-digit product format
- 670461519
- Labeler code
- 67046
- Product ID
- 67046-1519_2e07a4ba-25fe-a248-e063-6294a90abb0b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PRAVASTATIN SODIUM
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA077987
- Marketing category
- ANDA
- Marketing start
- 2025-02-13
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PRAVASTATIN SODIUM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PRAVASTATIN SODIUM | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3M8608UQ61 |
| Rxcui | 904467 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67046-1519-3 | PRAVASTATIN SODIUM | 30 in 1 BLISTER PACK | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67046-1519 | PRAVASTATIN SODIUM TABLET [COUPLER LLC] | 1 | Current NDC, 1 package rows | 20250215_2e07ad78-1059-e0ec-e063-6394a90a9bff.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1519-3 | 67046151903 | 30 TABLET in 1 BLISTER PACK (67046-1519-3) | 30 tablet | 2025-02-13 | No | No | Historical |