simvastatin
- Product NDC
- 43063-733
- 11-digit product format
- 430630733
- Labeler code
- 43063
- Product ID
- 43063-733_51a5e93d-b458-c3b7-e063-6294a90a7165
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078155
- Marketing category
- ANDA
- Marketing start
- 2008-02-26
- 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 | 200345 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-733-30 | simvastatin | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 26 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-733 | SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 24 | Current NDC, Legacy NDC, 1 package rows | 20240820_c6b610ab-7367-4e61-9b4a-7ebbd1cf3d36.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 |
|---|
| 43063-733-30 | 43063073330 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-733-30) | 2016-12-28 | 0000-00-00 | No | No | Current |