SIMVASTATIN
- Product NDC
- 50090-4736
- 11-digit product format
- 500904736
- Labeler code
- 50090
- Product ID
- 50090-4736_9f5cb785-eced-4a37-8e92-3fb5a2e2e60f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SIMVASTATIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2016-02-19
- Substance
- SIMVASTATIN
- Active strength
- 40 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SIMVASTATIN
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SIMVASTATIN | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AGG2FN16EV |
| Rxcui | 198211 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-4736-1 | 2023-02-07 | C162847 | 48780-1 | f386c649-eb13-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991 |
| 50090-4736-2 | 2023-02-07 | C162847 | 48780-1 | f386c649-eb13-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991 |
| 50090-4736-3 | 2023-02-07 | C162847 | 48780-1 | f386c649-eb13-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991 |
| 50090-4736-4 | 2023-02-07 | C162847 | 48780-1 | f386c649-eb13-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991 |
| 50090-4736-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-eb13-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991 |
| 50090-4736-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-eb13-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991 |
| 50090-4736-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-eb13-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991 |
| 50090-4736-4 | 2023-01-30 | C162847 | 48780-1 | f386c649-eb13-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use SIMVASTATIN TABLETS safely and effectively. See full prescribing information for SIMVASTATIN TABLETS. SIMVASTATIN tablets, for oral use Initial U.S. Approval: 1991 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-4736-0 | SIMVASTATIN | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 12 |
| 50090-4736-1 | SIMVASTATIN | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 12 |
| 50090-4736-2 | SIMVASTATIN | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 12 |
| 50090-4736-3 | SIMVASTATIN | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 12 |
| 50090-4736-4 | SIMVASTATIN | 200 in 1 BOTTLE | TABLET, FILM COATED | 200 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-4736 | SIMVASTATIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 10 | Current NDC, Legacy NDC, 5 package rows | 20241017_3b0720d2-b240-48e4-af77-9ccda509fae7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-4736-0 | 50090473600 | 1000 TABLET, FILM COATED in 1 BOTTLE (50090-4736-0) | 2019-11-19 | | No | No | Historical |
| 50090-4736-1 | 50090473601 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-4736-1) | 2019-11-19 | 0000-00-00 | No | No | Current |
| 50090-4736-2 | 50090473602 | 100 TABLET, FILM COATED in 1 BOTTLE (50090-4736-2) | 2019-11-19 | 0000-00-00 | No | No | Current |
| 50090-4736-3 | 50090473603 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-4736-3) | 2019-11-19 | 0000-00-00 | No | No | Current |
| 50090-4736-4 | 50090473604 | 200 TABLET, FILM COATED in 1 BOTTLE (50090-4736-4) | 2019-11-19 | 0000-00-00 | No | No | Current |