Pravastatin Sodium
- Product NDC
- 21695-180
- 11-digit product format
- 216950180
- Labeler code
- 21695
- Product ID
- 21695-180_762daef1-2ad2-444d-958b-f0a69c8ac259
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pravastatin Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA076939
- 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
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|---|---|---|---|---|
| 21695-180-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-49b3-48b1-e053-8cdaa90a720a | PRAVASTATIN SODIUM TABLETS USP |
| 21695-180-90 | 2019-09-24 | C162847 | 48780-1 | 934fe258-49b3-48b1-e053-8cdaa90a720a | PRAVASTATIN SODIUM TABLETS USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-180-30 | Pravastatin Sodium | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 1 | |
| 21695-180-90 | Pravastatin Sodium | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-180-30 | EA - Each | 21695-180 | a04ed36e-bf44-4655-aa70-b499014684c2 | 1 | 2012-07-24 |
| 21695-180-90 | EA - Each | 21695-180 | 44f09f05-a35e-4e68-a29d-98715bd93dad | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| pravastatin sodium | ACTIVE INGREDIENT | 3M8608UQ61 | PRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| pravastatin | ACTIVE MOIETY | KXO2KT9N0G | PRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | PRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | PRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| magnesium aluminum silicate | INACTIVE INGREDIENT | 6M3P64V0NC | PRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | PRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | PRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | PRAVASTATIN SODIUM TABLET [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 904458 | pravastatin sodium 10 MG Oral Tablet | PSN | 762daef1-2ad2-444d-958b-f0a69c8ac259 | 1 |
| 904467 | pravastatin sodium 20 MG Oral Tablet | PSN | 762daef1-2ad2-444d-958b-f0a69c8ac259 | 1 |
| 904475 | pravastatin sodium 40 MG Oral Tablet | PSN | 762daef1-2ad2-444d-958b-f0a69c8ac259 | 1 |
| 904458 | pravastatin sodium 10 MG Oral Tablet | SCD | 762daef1-2ad2-444d-958b-f0a69c8ac259 | 1 |
| 904467 | pravastatin sodium 20 MG Oral Tablet | SCD | 762daef1-2ad2-444d-958b-f0a69c8ac259 | 1 |
| 904475 | pravastatin sodium 40 MG Oral Tablet | SCD | 762daef1-2ad2-444d-958b-f0a69c8ac259 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-180-30 | 21695018030 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 21695-180-90 | 21695018090 | 90 in 1 BOTTLE, PLASTIC | Historical |