Simvastatin
- Product NDC
- 55111-198
- 11-digit product format
- 551110198
- Labeler code
- 55111
- Product ID
- 55111-198_84334c5d-1663-972c-5d96-03eb1be16f64
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Limited
- Application
- ANDA077752
- Marketing category
- ANDA
- Marketing start
- 2006-12-20
- Marketing end
- 0000-00-00
- Substance
- SIMVASTATIN
- Active strength
- 10 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 Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Simvastatin | ACTIVE INGREDIENT | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 9 | |
| Simvastatin | ACTIVE MOIETY | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 9 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 9 | |
| ascorbic acid | INACTIVE INGREDIENT | PQ6CK8PD0R | SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 9 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 9 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 9 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 9 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 9 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 9 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 9 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 9 | |
| isopropyl alcohol | INACTIVE INGREDIENT | ND2M416302 | SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 9 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 9 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 9 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 9 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-198 | SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 14 | Legacy NDC | 20190312_d9a1a7c5-d806-4dbd-a201-5e73790d078b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55111-198-01 | 55111019801 | 100 TABLET, FILM COATED in 1 BOTTLE (55111-198-01) | | 2006-12-20 | 0000-00-00 | No | No | Current |
| 55111-198-05 | 55111019805 | 500 TABLET, FILM COATED in 1 BOTTLE (55111-198-05) | | 2006-12-20 | 0000-00-00 | No | No | Current |
| 55111-198-30 | 55111019830 | 30 TABLET, FILM COATED in 1 BOTTLE (55111-198-30) | | 2006-12-20 | 0000-00-00 | No | No | Current |
| 55111-198-60 | 55111019860 | 60 TABLET, FILM COATED in 1 BOTTLE (55111-198-60) | | 2006-12-20 | 0000-00-00 | No | No | Current |
| 55111-198-78 | 55111019878 | 10 DOSE PACK in 1 BOX (55111-198-78) > 10 TABLET, FILM COATED in 1 DOSE PACK | 10 dose pack | 2006-12-20 | 0000-00-00 | No | No | Current |
| 55111-198-90 | 55111019890 | 90 TABLET, FILM COATED in 1 BOTTLE (55111-198-90) | | 2006-12-20 | 0000-00-00 | No | No | Current |