Rosuvastatin

Product NDC: 69238-1148
11-digit product format: 692381148
Labeler code: 69238
Product ID: 69238-1148_da716d5f-ee56-4911-95c9-87d4529067e9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rosuvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA208850
Marketing category: ANDA
Marketing start: 2018-10-22
Marketing end: 0000-00-00
Substance: ROSUVASTATIN CALCIUM
Active strength: 20 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69238-1148		D	Discontinued by firm		2026-10-05
excluded package	package	69238-1148	69238-1148-9	D	Discontinued by firm		2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A208850-001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2018-10-16
A208850-002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2018-10-16
A208850-003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2018-10-16
A208850-004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2018-10-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208850-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2018-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208850-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2018-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208850-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2018-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208850-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2018-10-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208850-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2018-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208850-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2018-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208850-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2018-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208850-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2018-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208850-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2018-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208850-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2018-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208850-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2018-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208850-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2018-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208850-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2018-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208850-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2018-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208850-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2018-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208850-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2018-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208850-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2018-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208850-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2018-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208850-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2018-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208850-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2018-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208850-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2018-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208850-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2018-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208850-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2018-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208850-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2018-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208850-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2018-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208850-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2018-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208850-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2018-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208850-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2018-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208850-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2018-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208850-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2018-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208850-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2018-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208850-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2018-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208850-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2018-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208850-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2018-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208850-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2018-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208850-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2018-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208850-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2018-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208850-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2018-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208850-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2018-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208850-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2018-10-16	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-1148	ROSUVASTATIN TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]	12	Legacy NDC	20241031_52435b49-6228-4a30-9992-2ea2e77ec7b1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
83MVU38M7Q	ROSUVASTATIN CALCIUM	147098-20-2	ROSUVASTATIN CALCIUM
413KH5ZJ73	ROSUVASTATIN	287714-41-4	Rosuvastatin

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69238-1148-9	69238114809	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69238-1148-9)	2018-10-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rosuvastatin	Amneal Pharmaceuticals NY LLC \| Amneal Pharmaceuticals Private Limited	2024-09-30	HUMAN PRESCRIPTION DRUG LABEL	12