pravastatin sodium
- Product NDC
- 68382-073
- 11-digit product format
- 683820073
- Labeler code
- 68382
- Product ID
- 68382-073_12014495-c66a-407e-aa7b-5c58596230ce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pravastatin sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA077751
- Marketing category
- ANDA
- Marketing start
- 2010-03-30
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 36361c23-a766-1581-d616-2080c781a50c | Product name | 5 | 20190314 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68382-073-05 | EA - Each | 68382-073 | 30882337-6157-4615-b8af-90136f60e6ab | 1 | 2012-07-24 |
| 68382-073-16 | EA - Each | 68382-073 | b43d7956-27b7-4066-b5cd-7cc52d4e9e4c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PRAVASTATIN SODIUM | ACTIVE INGREDIENT | 3M8608UQ61 | PRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| PRAVASTATIN | ACTIVE MOIETY | KXO2KT9N0G | PRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | PRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | PRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POLYOXYL 35 CASTOR OIL | INACTIVE INGREDIENT | 6D4M1DAL6O | PRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | PRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 904467 | pravastatin sodium 20 MG Oral Tablet | PSN | 087a93d5-0e68-4856-86a3-28964f60d6ff | 1 |
| 904475 | pravastatin sodium 40 MG Oral Tablet | PSN | 087a93d5-0e68-4856-86a3-28964f60d6ff | 1 |
| 904481 | pravastatin sodium 80 MG Oral Tablet | PSN | 087a93d5-0e68-4856-86a3-28964f60d6ff | 1 |
| 904467 | pravastatin sodium 20 MG Oral Tablet | SCD | 087a93d5-0e68-4856-86a3-28964f60d6ff | 1 |
| 904475 | pravastatin sodium 40 MG Oral Tablet | SCD | 087a93d5-0e68-4856-86a3-28964f60d6ff | 1 |
| 904481 | pravastatin sodium 80 MG Oral Tablet | SCD | 087a93d5-0e68-4856-86a3-28964f60d6ff | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68382-073-05 | 68382007305 | 500 TABLET in 1 BOTTLE (68382-073-05) | 500 tablet | 2010-03-30 | 0000-00-00 | No | No | Current |
| 68382-073-16 | 68382007316 | 90 TABLET in 1 BOTTLE (68382-073-16) | 90 tablet | 2010-03-30 | 0000-00-00 | No | No | Current |