Pravastatin Sodium
- Product NDC
- 0093-0771
- 11-digit product format
- 000930771
- Labeler code
- 0093
- Product ID
- 0093-0771_72579e23-23ef-4ab7-ad64-24d5ea7997eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pravastatin Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA076056
- Marketing category
- ANDA
- Marketing start
- 2006-04-25
- Marketing end
- 2026-09-30
- Substance
- PRAVASTATIN SODIUM
- Active strength
- 10 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pravastatin Sodium
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PRAVASTATIN SODIUM | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3M8608UQ61 |
| Rxcui | 904458, 904467, 904475 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-0771-10 | Pravastatin Sodium | 1000 in 1 BOTTLE | TABLET | 1000 | | 27 |
| 0093-0771-98 | Pravastatin Sodium | 90 in 1 BOTTLE | TABLET | 90 | | 27 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PRAVASTATIN SODIUM | ACTIVE INGREDIENT | 3M8608UQ61 | PRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC] | 12 | |
| PRAVASTATIN | ACTIVE MOIETY | KXO2KT9N0G | PRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC] | 12 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | PRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC] | 12 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | PRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC] | 12 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC] | 12 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | PRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC] | 12 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC] | 12 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | PRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA INC] | 12 | |
| PRAVASTATIN SODIUM | ACTIVE INGREDIENT | 3M8608UQ61 | PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.] | 9 | |
| PRAVASTATIN | ACTIVE MOIETY | KXO2KT9N0G | PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.] | 9 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.] | 9 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.] | 9 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.] | 9 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.] | 9 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.] | 9 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.] | 9 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.] | 9 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | PRAVASTATIN SODIUM TABLET [INTERNATIONAL LABS, INC.] | 9 | |
| PRAVASTATIN SODIUM | ACTIVE INGREDIENT | 3M8608UQ61 | PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| PRAVASTATIN SODIUM | ACTIVE INGREDIENT | 3M8608UQ61 | PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| PRAVASTATIN | ACTIVE MOIETY | KXO2KT9N0G | PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| PRAVASTATIN | ACTIVE MOIETY | KXO2KT9N0G | PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | PRAVASTATIN SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-0771 | PRAVASTATIN SODIUM TABLET [TEVA PHARMACEUTICALS USA, INC.] | 27 | Current NDC, Legacy NDC, 2 package rows | 20250507_99e0e848-f8f3-4b42-b880-8fbc42633948.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 |
|---|
| 0093-0771-10 | 00093077110 | 1000 TABLET in 1 BOTTLE (0093-0771-10) | 1000 tablet | 2008-03-07 | 2026-09-30 | No | No | Current |
| 0093-0771-98 | 00093077198 | 90 TABLET in 1 BOTTLE (0093-0771-98) | 90 tablet | 2006-04-25 | 2026-06-30 | No | No | Current |