Simvastatin
- Product NDC
- 43353-875
- 11-digit product format
- 433530875
- Labeler code
- 43353
- Product ID
- 43353-875_68513fbe-c3f6-42f4-8358-589aad365109
- 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
- 5 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-875-30 | Simvastatin | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 2 |
| 43353-875-60 | Simvastatin | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 2 |
| 43353-875-88 | 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 |
|---|
| 43353-875 | SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Legacy NDC, 3 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 | Status |
|---|
| 43353-875-30 | 43353087530 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 43353-875-60 | 43353087560 | 90 in 1 BOTTLE, PLASTIC | Historical |
| 43353-875-88 | 43353087588 | 900 in 1 BOTTLE, PLASTIC | Historical |