Simvastatin
- Product NDC
- 71335-1905
- 11-digit product format
- 713351905
- Labeler code
- 71335
- Product ID
- 71335-1905_410c02d5-08d3-4fd4-8130-26de1b6daaf2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078034
- Marketing category
- ANDA
- Marketing start
- 2015-12-17
- 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
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71335-1905_410c02d5-08d3-4fd4-8130-26de1b6daaf2
- SPL ID
- 410c02d5-08d3-4fd4-8130-26de1b6daaf2
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Simvastatin
- Generic name
- Simvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2015-12-17
- Marketing category
- ANDA
- Application number
- ANDA078034
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC]; Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| SIMVASTATIN | 10 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | AGG2FN16EV |
| Rxcui | 314231 |
| Spl Set Id | 4277e75a-7f3b-4f35-ae56-0bbe095586a5 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-1905-1 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1905-1) | 2021-09-08 | No |
| 71335-1905-2 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1905-2) | 2021-09-13 | No |
| 71335-1905-3 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1905-3) | 2021-12-29 | No |
| 71335-1905-4 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1905-4) | 2021-07-19 | No |
| 71335-1905-5 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1905-5) | 2021-12-29 | No |
| 71335-1905-6 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-1905-6) | 2021-12-29 | No |
| 71335-1905-7 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-1905-7) | 2021-12-29 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| AGG2FN16EV | SIMVASTATIN | 79902-63-9 | SIMVASTATIN |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-1905-1 | 71335190501 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1905-1) | 2021-09-08 | No | No | Historical |
| 71335-1905-2 | 71335190502 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1905-2) | 2021-09-13 | No | No | Historical |
| 71335-1905-3 | 71335190503 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1905-3) | 2021-12-29 | No | No | Historical |
| 71335-1905-4 | 71335190504 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1905-4) | 2021-07-19 | No | No | Historical |
| 71335-1905-5 | 71335190505 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1905-5) | 2021-12-29 | No | No | Historical |
| 71335-1905-6 | 71335190506 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-1905-6) | 2021-12-29 | No | No | Historical |
| 71335-1905-7 | 71335190507 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-1905-7) | 2021-12-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Simvastatin | Bryant Ranch Prepack | 2024-05-22 | HUMAN PRESCRIPTION DRUG LABEL | 103 |