Pravastatin Sodium
- Product NDC
- 35356-921
- 11-digit product format
- 353560921
- Labeler code
- 35356
- Product ID
- 35356-921_18f6fc71-e58c-45b4-842f-d6e90ad7677a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pravastatin sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA076341
- Marketing category
- ANDA
- Marketing start
- 2011-07-18
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 35356-921-30 | 2021-06-14 | C162847 | 48780-1 | ba0f9c33-4f1f-a910-e053-dadaa90a0b85 | Pravastatin Sodium Tablets, USP 10 mg, 20 mg, 40 mg and 80 mg |
| 35356-921-60 | 2021-06-14 | C162847 | 48780-1 | ba0f9c33-4f1f-a910-e053-dadaa90a0b85 | Pravastatin Sodium Tablets, USP 10 mg, 20 mg, 40 mg and 80 mg |
| 35356-921-90 | 2021-06-14 | C162847 | 48780-1 | ba0f9c33-4f1f-a910-e053-dadaa90a0b85 | Pravastatin Sodium Tablets, USP 10 mg, 20 mg, 40 mg and 80 mg |
| 35356-921-30 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4f1f-a910-e053-dadaa90a0b85 | Pravastatin Sodium Tablets, USP 10 mg, 20 mg, 40 mg and 80 mg |
| 35356-921-60 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4f1f-a910-e053-dadaa90a0b85 | Pravastatin Sodium Tablets, USP 10 mg, 20 mg, 40 mg and 80 mg |
| 35356-921-90 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4f1f-a910-e053-dadaa90a0b85 | Pravastatin Sodium Tablets, USP 10 mg, 20 mg, 40 mg and 80 mg |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 35356-921-30 | Pravastatin Sodium | 30 in 1 BOTTLE | TABLET | 30 | | 9 |
| 35356-921-60 | Pravastatin Sodium | 60 in 1 BOTTLE | TABLET | 60 | | 9 |
| 35356-921-90 | Pravastatin Sodium | 90 in 1 BOTTLE | TABLET | 90 | | 9 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 35356-921 | PRAVASTATIN SODIUM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 9 | Legacy NDC, 3 package rows | 20241213_e7194af1-6304-4e3e-88ab-0825706a3962.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 |
|---|
| 35356-921-30 | 35356092130 | 30 TABLET in 1 BOTTLE (35356-921-30) | 30 tablet | 2011-07-18 | 0000-00-00 | No | No | Current |
| 35356-921-60 | 35356092160 | 60 in 1 BOTTLE | | | | | | Historical |
| 35356-921-90 | 35356092190 | 90 in 1 BOTTLE | | | | | | Historical |