simvastatin
- Product NDC
- 16729-156
- 11-digit product format
- 167290156
- Labeler code
- 16729
- Product ID
- 16729-156_43910ff2-6a21-bf9e-e063-6294a90a3f5c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Accord Healthcare, Inc.
- Application
- ANDA078155
- Marketing category
- ANDA
- Marketing start
- 2014-09-12
- Substance
- SIMVASTATIN
- Active strength
- 5 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 | 5 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 |
|---|
| 16729-156-10 | simvastatin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 22 |
| 16729-156-15 | simvastatin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 22 |
| 16729-156-17 | simvastatin | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 22 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SIMVASTATIN | ACTIVE INGREDIENT | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 13 | |
| SIMVASTATIN | ACTIVE MOIETY | AGG2FN16EV | SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 13 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 13 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 13 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 13 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 13 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 13 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 13 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 13 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 13 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 13 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 13 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 13 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 13 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 13 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 13 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-156 | SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 21 | Current NDC, Legacy NDC, 3 package rows | 20240719_871251c0-36a1-4a32-9eab-ff6c1e925ca9.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 |
|---|
| 16729-156-10 | 16729015610 | 30 TABLET, FILM COATED in 1 BOTTLE (16729-156-10) | 2014-11-07 | 0000-00-00 | No | No | Current |
| 16729-156-15 | 16729015615 | 90 TABLET, FILM COATED in 1 BOTTLE (16729-156-15) | 2014-09-12 | 0000-00-00 | No | No | Current |
| 16729-156-17 | 16729015617 | 1000 TABLET, FILM COATED in 1 BOTTLE (16729-156-17) | 2015-04-22 | 0000-00-00 | No | No | Current |