Simvastatin
- Product NDC
- 63304-789
- 11-digit product format
- 633040789
- Labeler code
- 63304
- Product ID
- 63304-789_d005a31b-31ba-400e-a75c-99e6adf745bd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Ranbaxy Pharmaceuticals Inc.
- Application
- ANDA076285
- 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
- E
- Listing certified through
- 2018-12-31
- 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 |
|---|
| 63304-789-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7b88-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use simvastatin tablets, USP safely and effectively. See full prescribing information for simvastatin tablets, USP. Simvastatin tablets, USP Initial U.S. Approval: 1991 |
| 63304-789-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7b88-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use simvastatin tablets, USP safely and effectively. See full prescribing information for simvastatin tablets, USP. Simvastatin tablets, USP Initial U.S. Approval: 1991 |
| 63304-789-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7b88-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use simvastatin tablets, USP 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 |
|---|
| 63304-789-10 | Simvastatin | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 10 |
| 63304-789-30 | Simvastatin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 10 |
| 63304-789-90 | Simvastatin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SIMVASTATIN | ACTIVE INGREDIENT | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 10 | |
| SIMVASTATIN | ACTIVE MOIETY | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 10 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 10 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 10 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 10 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 10 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 10 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 10 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 10 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 10 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 10 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 10 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 10 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 10 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 10 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 10 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63304-789 | SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] | 10 | Legacy NDC, 3 package rows | 20140429_cdb54447-86a5-4924-a7de-ec170f86651d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 63304-789-10 | 63304078910 | 1000 in 1 BOTTLE | Historical |
| 63304-789-30 | 63304078930 | 30 in 1 BOTTLE | Historical |
| 63304-789-90 | 63304078990 | 90 in 1 BOTTLE | Historical |