Simvastatin
- Product NDC
- 43063-080
- 11-digit product format
- 430630080
- Labeler code
- 43063
- Product ID
- 43063-080_e6623cc1-d817-a4e8-e053-2995a90a11f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA077752
- Marketing category
- ANDA
- Marketing start
- 2006-12-20
- Marketing end
- 0000-00-00
- Substance
- SIMVASTATIN
- Active strength
- 80 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 Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Simvastatin | ACTIVE INGREDIENT | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| Simvastatin | ACTIVE MOIETY | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| ascorbic acid | INACTIVE INGREDIENT | PQ6CK8PD0R | SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| isopropyl alcohol | INACTIVE INGREDIENT | ND2M416302 | SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-080 | SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 17 | Legacy NDC | 20241012_7b12e944-46db-4de4-b515-20f59467b89d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-080-30 | 43063008030 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-080-30) | 2009-03-04 | 0000-00-00 | No | No | Current |
| 43063-080-90 | 43063008090 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-080-90) | 2009-03-04 | 0000-00-00 | No | No | Current |