Pravastatin Sodium
- Product NDC
- 69097-185
- 11-digit product format
- 690970185
- Labeler code
- 69097
- Product ID
- 69097-185_d21ccdc6-9fe2-48b6-87a4-238a09c4cf14
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pravastatin Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA077904
- Marketing category
- ANDA
- Marketing start
- 2006-10-23
- Marketing end
- 0000-00-00
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69097-185-05 | 2025-11-20 | C162847 | 48780-1 | 9d75b9d0-4042-f424-e053-dadaa90a57ce | 1743c691-c2f1-41d0-8977-bc97490ab39e |
| 69097-185-12 | 2025-11-20 | C162847 | 48780-1 | 9d75b9d0-4042-f424-e053-dadaa90a57ce | 1743c691-c2f1-41d0-8977-bc97490ab39e |
| 69097-185-15 | 2025-11-20 | C162847 | 48780-1 | 9d75b9d0-4042-f424-e053-dadaa90a57ce | 1743c691-c2f1-41d0-8977-bc97490ab39e |
| 69097-185-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4042-f424-e053-dadaa90a57ce | 1743c691-c2f1-41d0-8977-bc97490ab39e |
| 69097-185-12 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4042-f424-e053-dadaa90a57ce | 1743c691-c2f1-41d0-8977-bc97490ab39e |
| 69097-185-15 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4042-f424-e053-dadaa90a57ce | 1743c691-c2f1-41d0-8977-bc97490ab39e |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PRAVASTATIN SODIUM | ACTIVE INGREDIENT | 3M8608UQ61 | PRAVASTATIN SODIUM TABLET [CIPLA USA INC.] | 1 | |
| PRAVASTATIN | ACTIVE MOIETY | KXO2KT9N0G | PRAVASTATIN SODIUM TABLET [CIPLA USA INC.] | 1 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | PRAVASTATIN SODIUM TABLET [CIPLA USA INC.] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | PRAVASTATIN SODIUM TABLET [CIPLA USA INC.] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | PRAVASTATIN SODIUM TABLET [CIPLA USA INC.] | 1 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | PRAVASTATIN SODIUM TABLET [CIPLA USA INC.] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | PRAVASTATIN SODIUM TABLET [CIPLA USA INC.] | 1 |