SIMVASTATIN
- Product NDC
- 71205-192
- 11-digit product format
- 712050192
- Labeler code
- 71205
- Product ID
- 71205-192_3cd63811-b40d-47c5-9c50-c0a30bc68fcc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SIMVASTATIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2015-12-02
- Substance
- SIMVASTATIN
- Active strength
- 40 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 | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AGG2FN16EV |
| Rxcui | 198211 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71205-192-30 | SIMVASTATIN | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 71205-192-60 | SIMVASTATIN | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
| 71205-192-90 | SIMVASTATIN | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-192 | SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP] | 4 | Current NDC, Legacy NDC, 3 package rows | 20220421_7649bec7-04c6-47b5-a050-15923006dac0.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 |
|---|
| 71205-192-30 | 71205019230 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-192-30) | 2019-01-01 | 0000-00-00 | No | No | Current |
| 71205-192-60 | 71205019260 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-192-60) | 2019-01-01 | 0000-00-00 | No | No | Current |
| 71205-192-90 | 71205019290 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-192-90) | 2019-01-01 | 0000-00-00 | No | No | Current |