Simvastatin
- Product NDC
- 65727-069
- 11-digit product format
- 657270069
- Labeler code
- 65727
- Product ID
- 65727-069_3ff17740-c7a8-095b-f5fc-78e73ab285f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Biocon Limited
- Application
- ANDA078034
- Marketing category
- ANDA
- Marketing start
- 2015-12-17
- Marketing end
- 0000-00-00
- Substance
- SIMVASTATIN
- Active strength
- 80 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65727-069-12 | Simvastatin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 65727-069-13 | Simvastatin | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 2 |
| 65727-069-14 | Simvastatin | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
| 65727-069-15 | Simvastatin | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65727-069 | SIMVASTATIN TABLET, FILM COATED [BIOCON LIMITED] | 2 | Legacy NDC, 4 package rows | 20151217_7ad38e3b-79a8-f4c1-0662-c24f3e897ac7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 65727-069-12 | 65727006912 | 30 in 1 BOTTLE | Historical |
| 65727-069-13 | 65727006913 | 45 in 1 BOTTLE | Historical |
| 65727-069-14 | 65727006914 | 90 in 1 BOTTLE | Historical |
| 65727-069-15 | 65727006915 | 1000 in 1 BOTTLE | Historical |