Simvastatin
- Product NDC
- 43063-162
- 11-digit product format
- 430630162
- Labeler code
- 43063
- Product ID
- 43063-162_e6626fa6-ac7c-5c21-e053-2995a90af36a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA077752
- Marketing category
- ANDA
- Marketing start
- 2006-12-20
- Marketing end
- 0000-00-00
- Substance
- SIMVASTATIN
- Active strength
- 10 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-162 | SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 20 | Legacy NDC | 20241012_276fa728-279b-4272-e054-00144ff8d46c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-162-30 | 43063016230 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-162-30) | 2009-06-24 | 0000-00-00 | No | No | Current |