Pravastatin Sodium
- Product NDC
- 69292-102
- 11-digit product format
- 692920102
- Labeler code
- 69292
- Product ID
- 69292-102_52351ef8-7a5a-6e07-e063-6294a90af72a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pravastatin Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amici Pharma, Inc.
- Application
- ANDA077491
- Marketing category
- ANDA
- Marketing start
- 2026-05-19
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pravastatin Sodium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PRAVASTATIN SODIUM | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3M8608UQ61 |
| Rxcui | 904458, 904467, 904475, 904481 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69292-102-10 | Pravastatin Sodium | 1000 in 1 BOTTLE | TABLET | 1000 | | 2 |
| 69292-102-50 | Pravastatin Sodium | 500 in 1 BOTTLE | TABLET | 500 | | 2 |
| 69292-102-90 | Pravastatin Sodium | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69292-102-10 | 69292010210 | 1000 TABLET in 1 BOTTLE (69292-102-10) | 1000 tablet | 2026-05-19 | No | No | Current |
| 69292-102-50 | 69292010250 | 500 TABLET in 1 BOTTLE (69292-102-50) | 500 tablet | 2026-05-19 | No | No | Current |
| 69292-102-90 | 69292010290 | 90 TABLET in 1 BOTTLE (69292-102-90) | 90 tablet | 2026-05-19 | No | No | Current |