SIMVASTATIN
- Product NDC
- 68180-465
- 11-digit product format
- 681800465
- Labeler code
- 68180
- Product ID
- 68180-465_b78d4e8a-2261-43c6-9321-ac2539bdfd2f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SIMVASTATIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2016-01-05
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SIMVASTATIN
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SIMVASTATIN | 80 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AGG2FN16EV |
| Rxcui | 198211, 200345, 312961, 312962, 314231 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-465-03 | SIMVASTATIN | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 23 |
| 68180-465-06 | SIMVASTATIN | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 23 |
| 68180-465-09 | SIMVASTATIN | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 23 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SIMVASTATIN | ACTIVE INGREDIENT | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| SIMVASTATIN | ACTIVE MOIETY | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 6 | |
| SIMVASTATIN | ACTIVE INGREDIENT | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [DIRECT RX] | 5 | |
| SIMVASTATIN | ACTIVE MOIETY | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [DIRECT RX] | 5 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | SIMVASTATIN TABLET, FILM COATED [DIRECT RX] | 5 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | SIMVASTATIN TABLET, FILM COATED [DIRECT RX] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SIMVASTATIN TABLET, FILM COATED [DIRECT RX] | 5 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | SIMVASTATIN TABLET, FILM COATED [DIRECT RX] | 5 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | SIMVASTATIN TABLET, FILM COATED [DIRECT RX] | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | SIMVASTATIN TABLET, FILM COATED [DIRECT RX] | 5 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | SIMVASTATIN TABLET, FILM COATED [DIRECT RX] | 5 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | SIMVASTATIN TABLET, FILM COATED [DIRECT RX] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | SIMVASTATIN TABLET, FILM COATED [DIRECT RX] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SIMVASTATIN TABLET, FILM COATED [DIRECT RX] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SIMVASTATIN TABLET, FILM COATED [DIRECT RX] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SIMVASTATIN TABLET, FILM COATED [DIRECT RX] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SIMVASTATIN TABLET, FILM COATED [DIRECT RX] | 5 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | SIMVASTATIN TABLET, FILM COATED [DIRECT RX] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-465 | SIMVASTATIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] | 21 | Current NDC, Legacy NDC, 3 package rows | 20250515_3e48217f-8175-4e9b-9fd0-909be4bbba95.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 |
|---|
| 68180-465-03 | 68180046503 | 1000 TABLET, FILM COATED in 1 BOTTLE (68180-465-03) | 2016-03-09 | 0000-00-00 | No | No | Current |
| 68180-465-06 | 68180046506 | 30 TABLET, FILM COATED in 1 BOTTLE (68180-465-06) | 2016-01-05 | 0000-00-00 | No | No | Current |
| 68180-465-09 | 68180046509 | 90 TABLET, FILM COATED in 1 BOTTLE (68180-465-09) | 2016-02-19 | 0000-00-00 | No | No | Current |