Pravastatin sodium
- Product NDC
- 82868-096
- 11-digit product format
- 828680096
- Labeler code
- 82868
- Product ID
- 82868-096_471b4a51-f08f-52a6-e063-6294a90a32d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pravastatin sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA076056
- Marketing category
- ANDA
- Marketing start
- 2025-12-19
- 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
- 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 | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3M8608UQ61 |
| Rxcui | 904475 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82868-096-30 | Pravastatin sodium | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82868-096-30 | 82868009630 | 30 TABLET in 1 BOTTLE, PLASTIC (82868-096-30) | 30 tablet | 2025-12-19 | No | No | Current |