ROSUVASTATIN

Product NDC: 49252-062
11-digit product format: 492520062
Labeler code: 49252
Product ID: 49252-062_90429790-6bb4-40fe-bcb0-1121633523cc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rosuvastatin
Dosage form: TABLET
Route: ORAL
Labeler: Inventia Healthcare Limited
Application: ANDA207653
Marketing category: ANDA
Marketing start: 2021-02-05
Marketing end: 0000-00-00
Substance: ROSUVASTATIN CALCIUM
Active strength: 10 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49252-062		D	Discontinued by firm	2026-08-17
excluded package	package	49252-062	49252-062-10	D	Discontinued by firm	2026-08-17
excluded package	package	49252-062	49252-062-12	D	Discontinued by firm	2026-08-17
excluded package	package	49252-062	49252-062-17	D	Discontinued by firm	2026-08-17
excluded package	package	49252-062	49252-062-18	D	Discontinued by firm	2026-08-17
excluded package	package	49252-062	49252-062-57	D	Discontinued by firm	2026-08-17
excluded package	package	49252-062	49252-062-61	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 84 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49252-062-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49252-062-17	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49252-062-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49252-062-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49252-062-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49252-062-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49252-062-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49252-062-17	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49252-062-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49252-062-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49252-062-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49252-062-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49252-062-57	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49252-062-17	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49252-062-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49252-062-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49252-062-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49252-062-61	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49252-062-57	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49252-062-17	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49252-062-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49252-062-18	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49252-062-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49252-062-61	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49252-062-57	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49252-062-17	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49252-062-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49252-062-18	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49252-062-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49252-062-61	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49252-062-57	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49252-062-17	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49252-062-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49252-062-18	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49252-062-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49252-062-61	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49252-062-57	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49252-062-17	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49252-062-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49252-062-18	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49252-062-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49252-062-61	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49252-062-57	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49252-062-17	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49252-062-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49252-062-18	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49252-062-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49252-062-61	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49252-062-57	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49252-062-17	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49252-062-10	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A207653-001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05
A207653-002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05
A207653-003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05
A207653-004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05

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 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207653-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2021-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207653-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2021-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207653-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2021-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207653-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2021-02-05	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207653-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207653-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207653-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207653-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207653-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207653-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207653-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207653-004	AB	1	`5aa47cf7b7d7…`

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49252-062-10	49252006210	30 TABLET in 1 BOTTLE (49252-062-10)	30 tablet	2021-02-05	0000-00-00	No	No	Current
49252-062-12	49252006212	90 TABLET in 1 BOTTLE (49252-062-12)	90 tablet	2021-02-05	0000-00-00	No	No	Current
49252-062-17	49252006217	500 TABLET in 1 BOTTLE (49252-062-17)	500 tablet	2021-02-05	0000-00-00	No	No	Current
49252-062-18	49252006218	1000 TABLET in 1 BOTTLE (49252-062-18)	1000 tablet	2021-02-05	0000-00-00	No	No	Current
49252-062-57	49252006257	10 BLISTER PACK in 1 CARTON (49252-062-57) > 10 TABLET in 1 BLISTER PACK	10 blister pack	2021-02-05	0000-00-00	No	No	Current
49252-062-61	49252006261	10 BLISTER PACK in 1 CARTON (49252-062-61) > 10 TABLET in 1 BLISTER PACK	10 blister pack	2021-02-05	0000-00-00	No	No	Current