Rosuvastatin
- Product NDC
- 71335-2440
- 11-digit product format
- 713352440
- Labeler code
- 71335
- Product ID
- 71335-2440_34c2bf73-bed1-4495-89a7-f21dc7bc3437
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA206381
- Marketing category
- ANDA
- Marketing start
- 2019-04-24
- Substance
- ROSUVASTATIN
- Active strength
- 5 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
- 71335-2440_34c2bf73-bed1-4495-89a7-f21dc7bc3437
- SPL ID
- 34c2bf73-bed1-4495-89a7-f21dc7bc3437
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Rosuvastatin
- Generic name
- Rosuvastatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2019-04-24
- Marketing category
- ANDA
- Application number
- ANDA206381
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC]; Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| ROSUVASTATIN | 5 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 413KH5ZJ73 |
| Rxcui | 859424 |
| Spl Set Id | 4ba31486-c9e7-4361-b658-5464dc9ebc14 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-2440-1 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2440-1) | 2024-11-01 | No |
| 71335-2440-2 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2440-2) | 2024-07-17 | No |
| 71335-2440-3 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-2440-3) | 2024-11-01 | No |
| 71335-2440-4 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2440-4) | 2024-11-01 | No |
| 71335-2440-5 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2440-5) | 2024-11-01 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 413KH5ZJ73 | ROSUVASTATIN | 287714-41-4 | ROSUVASTATIN |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2440-1 | 71335244001 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2440-1) | 2024-11-01 | No | No | Historical |
| 71335-2440-2 | 71335244002 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2440-2) | 2024-07-17 | No | No | Historical |
| 71335-2440-3 | 71335244003 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-2440-3) | 2024-11-01 | No | No | Historical |
| 71335-2440-4 | 71335244004 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2440-4) | 2024-11-01 | No | No | Historical |
| 71335-2440-5 | 71335244005 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2440-5) | 2024-11-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rosuvastatin | Bryant Ranch Prepack | 2024-11-01 | HUMAN PRESCRIPTION DRUG LABEL | 2 |