Pravastatin sodium
- Product NDC
- 65862-633
- 11-digit product format
- 658620633
- Labeler code
- 65862
- Product ID
- 65862-633_6550d9a9-cf00-4ead-9b47-9e231212b769
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pravastatin sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA203367
- Marketing category
- ANDA
- Marketing start
- 2017-02-02
- 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 |
|---|
| 65862-633-05 | Pravastatin sodium | 500 in 1 BOTTLE | TABLET | 500 | | 7 |
| 65862-633-90 | Pravastatin sodium | 90 in 1 BOTTLE | TABLET | 90 | | 7 |
| 65862-633-99 | Pravastatin sodium | 1000 in 1 BOTTLE | TABLET | 1000 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-633 | PRAVASTATIN SODIUM TABLET [AUROBINDO PHARMA LIMITED] | 6 | Current NDC, Legacy NDC, 3 package rows | 20241220_b06ed801-ddee-4f56-924a-59fcb451eae6.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 |
|---|
| 65862-633-05 | 65862063305 | 500 TABLET in 1 BOTTLE (65862-633-05) | 500 tablet | 2017-02-02 | 0000-00-00 | No | No | Current |
| 65862-633-90 | 65862063390 | 90 TABLET in 1 BOTTLE (65862-633-90) | 90 tablet | 2017-02-02 | 0000-00-00 | No | No | Current |
| 65862-633-99 | 65862063399 | 1000 TABLET in 1 BOTTLE (65862-633-99) | 1000 tablet | 2017-02-02 | 0000-00-00 | No | No | Current |