PRAVASTATIN SODIUM
- Product NDC
- 82009-008
- 11-digit product format
- 820090008
- Labeler code
- 82009
- Product ID
- 82009-008_edcdc136-1cb4-26ac-2dc7-fcf26c4b5319
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PRAVASTATIN SODIUM
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Quallent
- Application
- ANDA076341
- Marketing category
- ANDA
- Marketing start
- 2021-12-03
- Substance
- PRAVASTATIN SODIUM
- Active strength
- 80 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 | 80 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3M8608UQ61 |
| Rxcui | 904467, 904475, 904481 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82009-008-05 | PRAVASTATIN SODIUM | 500 in 1 BOTTLE | TABLET | 500 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82009-008 | PRAVASTATIN SODIUM TABLET [QUALLENT] | 7 | Current NDC, Legacy NDC, 1 package rows | 20241228_e9c188f7-cd6f-afac-b493-36552d86589e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 82009-008-05 | 82009000805 | 500 TABLET in 1 BOTTLE (82009-008-05) | 500 tablet | 2021-12-03 | 0000-00-00 | No | No | Current |