Simvastatin
- Product NDC
- 68084-512
- 11-digit product format
- 680840512
- Labeler code
- 68084
- Product ID
- 68084-512_3d373f90-e8bd-1014-e063-6294a90aa882
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2011-09-08
- Substance
- SIMVASTATIN
- Active strength
- 20 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Simvastatin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SIMVASTATIN | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AGG2FN16EV |
| Rxcui | 312961, 314231 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68084-512-01 | Simvastatin | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 100 | | 13 |
| 68084-512-11 | Simvastatin | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SIMVASTATIN | ACTIVE INGREDIENT | AGG2FN16EV | SIMVASTATIN TABLET [CARDINAL HEALTH] | 5 | |
| SIMVASTATIN | ACTIVE MOIETY | AGG2FN16EV | SIMVASTATIN TABLET [CARDINAL HEALTH] | 5 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | SIMVASTATIN TABLET [CARDINAL HEALTH] | 5 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | SIMVASTATIN TABLET [CARDINAL HEALTH] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SIMVASTATIN TABLET [CARDINAL HEALTH] | 5 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | SIMVASTATIN TABLET [CARDINAL HEALTH] | 5 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | SIMVASTATIN TABLET [CARDINAL HEALTH] | 5 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | SIMVASTATIN TABLET [CARDINAL HEALTH] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SIMVASTATIN TABLET [CARDINAL HEALTH] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | SIMVASTATIN TABLET [CARDINAL HEALTH] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SIMVASTATIN TABLET [CARDINAL HEALTH] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SIMVASTATIN TABLET [CARDINAL HEALTH] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SIMVASTATIN TABLET [CARDINAL HEALTH] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SIMVASTATIN TABLET [CARDINAL HEALTH] | 5 | |
| SIMVASTATIN | ACTIVE INGREDIENT | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| SIMVASTATIN | ACTIVE MOIETY | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-512 | SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 12 | Current NDC, Legacy NDC, 2 package rows | 20241010_4bec3923-6221-4b8b-9a72-872a63680de1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68084-512-01 | 68084051201 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-512-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-512-11) | 100 blister pack | 2011-09-08 | 0000-00-00 | No | No | Current |
| 68084-512-11 | 68084051211 | 1 in 1 BLISTER PACK | | | | | | Historical |