SIMVASTATIN
- Product NDC
- 42708-168
- 11-digit product format
- 427080168
- Labeler code
- 42708
- Product ID
- 42708-168_46821a28-d545-b541-e063-6294a90a8d5d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SIMVASTATIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- QPharma, Inc.
- Application
- ANDA078103
- Marketing category
- ANDA
- Marketing start
- 2016-02-19
- 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 |
|---|
| 42708-168-30 | SIMVASTATIN | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42708-168 | SIMVASTATIN TABLET, FILM COATED [QPHARMA INC] | 3 | Current NDC, 1 package rows | 20240515_f71f71db-e0dd-6609-e053-6294a90a4450.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42708-168-30 | 42708016830 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42708-168-30) | 2023-03-20 | Yes | No | Current |