PRAVASTATIN SODIUM
- Product NDC
- 0615-8539
- 11-digit product format
- 006158539
- Labeler code
- 0615
- Product ID
- 0615-8539_78590b33-7097-47fe-8a37-034aea661387
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PRAVASTATIN SODIUM
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA077987
- Marketing category
- ANDA
- Marketing start
- 2024-06-01
- Marketing end
- 2026-10-31
- 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, 904481 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8539-39 | PRAVASTATIN SODIUM | 30 in 1 BLISTER PACK | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8539 | PRAVASTATIN SODIUM TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 2 | Current NDC, 1 package rows | 20241208_27ba8a69-b5aa-40eb-89f7-6bf2c1fcceae.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 |
|---|
| 0615-8539-39 | 00615853939 | 30 TABLET in 1 BLISTER PACK (0615-8539-39) | 30 tablet | 2024-11-19 | 2026-10-31 | No | No | Historical |