Simvastatin
- Product NDC
- 43353-856
- 11-digit product format
- 433530856
- Labeler code
- 43353
- Product ID
- 43353-856_f9ed59e7-0b07-4129-afb9-e7e546575a0b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077691
- Marketing category
- ANDA
- Marketing start
- 2006-12-20
- Marketing end
- 0000-00-00
- 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
- 2020-12-31
- 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 |
|---|
| 43353-856-15 | 2023-01-30 | C162847 | 48780-1 | f386c649-e652-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin tablets, USP. Simvastatin Tablets, USP Initial U.S. Approval: 1991 |
| 43353-856-17 | 2023-01-30 | C162847 | 48780-1 | f386c649-e652-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin tablets, USP. Simvastatin Tablets, USP Initial U.S. Approval: 1991 |
| 43353-856-30 | 2023-01-30 | C162847 | 48780-1 | f386c649-e652-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin tablets, USP. Simvastatin Tablets, USP Initial U.S. Approval: 1991 |
| 43353-856-45 | 2023-01-30 | C162847 | 48780-1 | f386c649-e652-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin tablets, USP. Simvastatin Tablets, USP Initial U.S. Approval: 1991 |
| 43353-856-60 | 2023-01-30 | C162847 | 48780-1 | f386c649-e652-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin tablets, USP. Simvastatin Tablets, USP Initial U.S. Approval: 1991 |
| 43353-856-88 | 2023-01-30 | C162847 | 48780-1 | f386c649-e652-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin tablets, USP. Simvastatin Tablets, USP Initial U.S. Approval: 1991 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-856-15 | Simvastatin | 15 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 15 | | 2 |
| 43353-856-17 | Simvastatin | 6030 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 6030 | | 2 |
| 43353-856-30 | Simvastatin | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 2 |
| 43353-856-45 | Simvastatin | 45 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 45 | | 2 |
| 43353-856-60 | Simvastatin | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 2 |
| 43353-856-88 | Simvastatin | 900 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 900 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SIMVASTATIN | ACTIVE INGREDIENT | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SIMVASTATIN | ACTIVE MOIETY | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-856 | SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Legacy NDC, 6 package rows | 20191224_1d7c107b-64f3-41b0-88c5-4f38dc58ceaf.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 |
|---|
| 43353-856-15 | 43353085615 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-856-15) | 2013-07-16 | 0000-00-00 | No | No | Current |
| 43353-856-17 | 43353085617 | 6030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-856-17) | 2013-12-17 | 0000-00-00 | No | No | Current |
| 43353-856-30 | 43353085630 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-856-30) | 2013-08-13 | 0000-00-00 | No | No | Current |
| 43353-856-45 | 43353085645 | 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-856-45) | 2013-10-28 | 0000-00-00 | No | No | Current |
| 43353-856-60 | 43353085660 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-856-60) | 2013-12-16 | 0000-00-00 | No | No | Current |
| 43353-856-88 | 43353085688 | 900 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-856-88) | 2013-12-20 | 0000-00-00 | No | No | Current |