Pravastatin sodium
- Product NDC
- 84386-034
- 11-digit product format
- 843860034
- Labeler code
- 84386
- Product ID
- 84386-034_c21d4797-d252-4073-891f-330484c5f643
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pravastatin sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA077793
- Marketing category
- ANDA
- Marketing start
- 2025-02-27
- 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 | 904481 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84386-034-90 | Pravastatin sodium | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
| 84386-034-99 | Pravastatin sodium | 1000 in 1 BOTTLE | TABLET | 1000 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 84386-034 | PRAVASTATIN SODIUM TABLET [AUROBINDO PHARMA LIMITED] | 1 | Current NDC, 2 package rows | 20250302_c21d4797-d252-4073-891f-330484c5f643.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 |
|---|
| 84386-034-90 | 84386003490 | 90 TABLET in 1 BOTTLE (84386-034-90) | 90 tablet | 2025-02-27 | No | No | Current |
| 84386-034-99 | 84386003499 | 1000 TABLET in 1 BOTTLE (84386-034-99) | 1000 tablet | 2025-02-27 | No | No | Current |