Rosuvastatin

Product NDC: 71335-2539
11-digit product format: 713352539
Labeler code: 71335
Product ID: 71335-2539_c6941a72-abca-4e4c-a315-b7d054702720
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: 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: 71335-2539_c6941a72-abca-4e4c-a315-b7d054702720
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

Ingredient	Strength
ROSUVASTATIN	10 mg/1

UNII	Preferred term	Registry number	Matched term
413KH5ZJ73	ROSUVASTATIN	287714-41-4	ROSUVASTATIN

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-2539-1	71335253901	30 TABLET, FILM COATED in 1 BOTTLE (71335-2539-1)	2024-12-10	No	No	Current
71335-2539-2	71335253902	90 TABLET, FILM COATED in 1 BOTTLE (71335-2539-2)	2024-12-10	No	No	Current
71335-2539-3	71335253903	60 TABLET, FILM COATED in 1 BOTTLE (71335-2539-3)	2024-12-10	No	No	Current
71335-2539-4	71335253904	120 TABLET, FILM COATED in 1 BOTTLE (71335-2539-4)	2024-12-10	No	No	Current
71335-2539-5	71335253905	180 TABLET, FILM COATED in 1 BOTTLE (71335-2539-5)	2024-12-10	No	No	Current
71335-2539-6	71335253906	100 TABLET, FILM COATED in 1 BOTTLE (71335-2539-6)	2024-12-10	No	No	Current

Title	Manufacturer	Effective date	Type	Version
Rosuvastatin	Bryant Ranch Prepack	2024-12-10	HUMAN PRESCRIPTION DRUG LABEL	1