pravastatin sodium
- Product NDC
- 53808-0685
- 11-digit product format
- 538080685
- Labeler code
- 53808
- Product ID
- 53808-0685_165010e0-5a9f-4e65-be43-ddb6999b5666
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pravastatin sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA077751
- Marketing category
- ANDA
- Marketing start
- 2013-01-01
- Marketing end
- 0000-00-00
- Substance
- PRAVASTATIN SODIUM
- Active strength
- 10 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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 36361c23-a766-1581-d616-2080c781a50c | Product name | 5 | 20190314 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53808-0685-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7bb8-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use pravastatin sodium safely and effectively. See full prescribing information for pravastatin sodium tablets. Initial U.S. Approval: 1991 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53808-0685-1 | pravastatin sodium | 30 in 1 BLISTER PACK | TABLET | 30 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PRAVASTATIN SODIUM | ACTIVE INGREDIENT | 3M8608UQ61 | PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| PRAVASTATIN | ACTIVE MOIETY | KXO2KT9N0G | PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 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 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POLYOXYL 35 CASTOR OIL | INACTIVE INGREDIENT | 6D4M1DAL6O | PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53808-0685 | PRAVASTATIN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | Legacy NDC, 1 package rows | 20140415_a8896399-04cd-42d7-894f-88ffc92f1557.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 904458 | pravastatin sodium 10 MG Oral Tablet | PSN | a8896399-04cd-42d7-894f-88ffc92f1557 | 1 |
| 904458 | pravastatin sodium 10 MG Oral Tablet | SCD | a8896399-04cd-42d7-894f-88ffc92f1557 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53808-0685-1 | 53808068501 | 30 in 1 BLISTER PACK | Historical |