CRESTOR

Product NDC: 43353-031
11-digit product format: 433530031
Labeler code: 43353
Product ID: 43353-031_0291bd29-faa4-4aa9-83f6-7cb28c229413
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rosuvastatin calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA021366
Marketing category: NDA
Marketing start: 2003-08-18
Marketing end: 0000-00-00
Substance: ROSUVASTATIN CALCIUM
Active strength: 40 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
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	43353-031		I	Inactivated by FDA	2026-10-12
excluded package	package	43353-031	43353-031-15	I	Inactivated by FDA	2026-10-12
excluded package	package	43353-031	43353-031-45	I	Inactivated by FDA	2026-10-12
excluded package	package	43353-031	43353-031-60	I	Inactivated by FDA	2026-10-12
excluded package	package	43353-031	43353-031-82	I	Inactivated by FDA	2026-10-12
excluded package	package	43353-031	43353-031-91	I	Inactivated by FDA	2026-10-12
excluded package	package	43353-031	43353-031-99	I	Inactivated by FDA	2026-10-12

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 3 · 147 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	43353-031-82	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-031-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-031-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-031-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-031-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-031-15	`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	43353-031-82	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-031-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-031-99	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-031-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-031-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-031-15	`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	43353-031-82	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-031-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-031-99	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-031-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-031-91	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-031-15	`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	43353-031-82	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-031-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-031-99	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-031-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-031-91	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-031-15	`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	43353-031-82	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-031-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-031-99	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-031-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-031-91	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-031-15	`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	43353-031-82	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-031-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-031-99	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-031-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-031-91	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-031-15	`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	43353-031-82	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-031-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-031-99	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-031-45	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-031-91	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-031-15	`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	43353-031-82	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-031-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-031-99	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-031-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-031-91	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-031-15	`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	43353-031-82	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-031-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-031-99	`0efc9e666f02…`	`f202fb6c5f17…`

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	TE codes	RLD / RS	Approval date
N021366-002	CRESTOR	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2003-08-12
N021366-003	CRESTOR	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2003-08-12
N021366-004	CRESTOR	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	RLD	2003-08-12
N021366-005	CRESTOR	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	2003-08-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N021366-002	AB
N021366-003	AB
N021366-004	AB
N021366-005	AB

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021366-002	CRESTOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021366-003	CRESTOR	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021366-004	CRESTOR	EQ 20MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021366-005	CRESTOR	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	2003-08-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021366-002	CRESTOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021366-003	CRESTOR	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021366-004	CRESTOR	EQ 20MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021366-005	CRESTOR	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	2003-08-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021366-002	CRESTOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021366-003	CRESTOR	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021366-004	CRESTOR	EQ 20MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021366-005	CRESTOR	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	2003-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021366-002	CRESTOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021366-003	CRESTOR	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021366-004	CRESTOR	EQ 20MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021366-005	CRESTOR	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	2003-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021366-002	CRESTOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021366-003	CRESTOR	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021366-004	CRESTOR	EQ 20MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021366-005	CRESTOR	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	2003-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021366-002	CRESTOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021366-003	CRESTOR	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021366-004	CRESTOR	EQ 20MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021366-005	CRESTOR	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	2003-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021366-002	CRESTOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021366-003	CRESTOR	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021366-004	CRESTOR	EQ 20MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021366-005	CRESTOR	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	2003-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021366-002	CRESTOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021366-003	CRESTOR	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021366-004	CRESTOR	EQ 20MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021366-005	CRESTOR	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	2003-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021366-002	CRESTOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021366-003	CRESTOR	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021366-004	CRESTOR	EQ 20MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021366-005	CRESTOR	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	2003-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021366-002	CRESTOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021366-003	CRESTOR	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021366-004	CRESTOR	EQ 20MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021366-005	CRESTOR	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	2003-08-12	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021366-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021366-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021366-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021366-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021366-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021366-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021366-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021366-005	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021366-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021366-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021366-004	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021366-005	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021366-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021366-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021366-004	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021366-005	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021366-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021366-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021366-004	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021366-005	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021366-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021366-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021366-004	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021366-005	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021366-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021366-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021366-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021366-005	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021366-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021366-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021366-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021366-005	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021366-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021366-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021366-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021366-005	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021366-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-005	AB	1	`74a2ff9319b5…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 222 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021366-002	6858618*PED	2022-06-17		Pediatric extension	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021366-003	6858618*PED	2022-06-17		Pediatric extension	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021366-004	6858618*PED	2022-06-17		Pediatric extension	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021366-005	6858618*PED	2022-06-17		Pediatric extension	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021366-002	6858618*PED	2022-06-17		Pediatric extension	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021366-003	6858618*PED	2022-06-17		Pediatric extension	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021366-004	6858618*PED	2022-06-17		Pediatric extension	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021366-005	6858618*PED	2022-06-17		Pediatric extension	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021366-002	6858618*PED	2022-06-17		Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021366-003	6858618*PED	2022-06-17		Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021366-004	6858618*PED	2022-06-17		Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021366-005	6858618*PED	2022-06-17		Pediatric extension	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021366-002	6316460	2020-08-04		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-002	6316460*PED	2021-02-04		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-002	6858618	2021-12-17	U-618		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-002	6858618	2021-12-17	U-1807		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-002	6858618	2021-12-17	U-1032		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-002	6858618*PED	2022-06-17		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-003	6316460	2020-08-04		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-003	6316460*PED	2021-02-04		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-003	6858618	2021-12-17	U-1032		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-003	6858618	2021-12-17	U-618		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-003	6858618	2021-12-17	U-1807		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-003	6858618*PED	2022-06-17		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-004	6316460	2020-08-04		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-004	6316460*PED	2021-02-04		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-004	6858618	2021-12-17	U-1032		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-004	6858618	2021-12-17	U-618		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-004	6858618	2021-12-17	U-1807		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-004	6858618*PED	2022-06-17		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-005	6316460	2020-08-04		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-005	6316460*PED	2021-02-04		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-005	6858618	2021-12-17	U-618		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-005	6858618*PED	2022-06-17		Pediatric extension	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021366-002	6858618*PED	2022-06-17		Pediatric extension	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021366-003	6858618*PED	2022-06-17		Pediatric extension	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021366-004	6858618*PED	2022-06-17		Pediatric extension	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021366-005	6858618*PED	2022-06-17		Pediatric extension	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021366-002	6316460*PED	2021-02-04		Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021366-002	6858618	2021-12-17	U-618		`782e0a99824c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 100 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021366-002	ODE-118	2023-05-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021366-003	ODE-118	2023-05-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021366-004	ODE-118	2023-05-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021366-005	ODE-118	2023-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021366-002	ODE-118	2023-05-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021366-003	ODE-118	2023-05-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021366-004	ODE-118	2023-05-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021366-005	ODE-118	2023-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021366-002	ODE-118	2023-05-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021366-003	ODE-118	2023-05-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021366-004	ODE-118	2023-05-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021366-005	ODE-118	2023-05-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021366-002	ODE-118	2023-05-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-003	ODE-118	2023-05-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-004	I-732	2019-05-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-004	ODE-118	2023-05-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021366-005	ODE-118	2023-05-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021366-002	ODE-118	2023-05-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021366-003	ODE-118	2023-05-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021366-004	ODE-118	2023-05-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021366-005	ODE-118	2023-05-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021366-002	ODE-118	2023-05-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021366-003	ODE-118	2023-05-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021366-004	ODE-118	2023-05-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021366-005	ODE-118	2023-05-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021366-002	ODE-118	2023-05-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021366-003	ODE-118	2023-05-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021366-004	ODE-118	2023-05-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021366-005	ODE-118	2023-05-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021366-002	ODE-118	2023-05-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021366-003	ODE-118	2023-05-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021366-004	ODE-118	2023-05-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021366-005	ODE-118	2023-05-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021366-002	ODE-118	2023-05-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021366-003	ODE-118	2023-05-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021366-004	ODE-118	2023-05-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021366-005	ODE-118	2023-05-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021366-002	ODE-118	2023-05-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021366-003	ODE-118	2023-05-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021366-004	ODE-118	2023-05-27	`c0c555d07b60…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c8f25656-847a-4de8-96a7-06bf98d83c2b	Product name	1	20210916
b6a872b4-e31a-fff0-6f62-fd0253265e2f	Product name	9	20190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5	Product name	1	20190429

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
43353-031-15	These highlights do not include all the information needed to use CRESTOR safely and effectively. See full prescribing information for CRESTOR. CRESTOR (rosuvastatin calcium) tablets Initial U.S. Approval: 2003
43353-031-45	These highlights do not include all the information needed to use CRESTOR safely and effectively. See full prescribing information for CRESTOR. CRESTOR (rosuvastatin calcium) tablets Initial U.S. Approval: 2003
43353-031-60	These highlights do not include all the information needed to use CRESTOR safely and effectively. See full prescribing information for CRESTOR. CRESTOR (rosuvastatin calcium) tablets Initial U.S. Approval: 2003
43353-031-82	These highlights do not include all the information needed to use CRESTOR safely and effectively. See full prescribing information for CRESTOR. CRESTOR (rosuvastatin calcium) tablets Initial U.S. Approval: 2003
43353-031-91	These highlights do not include all the information needed to use CRESTOR safely and effectively. See full prescribing information for CRESTOR. CRESTOR (rosuvastatin calcium) tablets Initial U.S. Approval: 2003
43353-031-99	These highlights do not include all the information needed to use CRESTOR safely and effectively. See full prescribing information for CRESTOR. CRESTOR (rosuvastatin calcium) tablets Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-031-15	CRESTOR	15 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	15	2
43353-031-45	CRESTOR	45 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	45	2
43353-031-60	CRESTOR	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	2
43353-031-82	CRESTOR	1200 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1200	2
43353-031-91	CRESTOR	1260 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1260	2
43353-031-99	CRESTOR	600 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	600	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-031-15	EA - Each	43353-031	2e176490-2d21-44ce-a287-1653aa25594e	1	2014-05-02
43353-031-45	EA - Each	43353-031	a6687bee-b7cf-45d9-ae91-604c588012eb	1	2014-05-02
43353-031-60	EA - Each	43353-031	9679e910-48b7-4a83-a102-cdb5c5843177	1	2014-05-02
43353-031-82	EA - Each	43353-031	f61a9953-2089-4a38-a2fb-928051ac7803	1	2014-05-02
43353-031-91	EA - Each	43353-031	f4500624-df81-4b39-991f-15ffa60e4edb	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ROSUVASTATIN CALCIUM	ACTIVE INGREDIENT	83MVU38M7Q	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
ROSUVASTATIN	ACTIVE MOIETY	413KH5ZJ73	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TRIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	91D9GV0Z28	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-031	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC, 6 package rows	20140410_3ec57aa3-4399-46c9-9292-567d2a09df4f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
83MVU38M7Q	ROSUVASTATIN CALCIUM	147098-20-2	ROSUVASTATIN CALCIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
859749	CRESTOR 10 MG Oral Tablet	PSN	3ec57aa3-4399-46c9-9292-567d2a09df4f	2
859753	CRESTOR 20 MG Oral Tablet	PSN	3ec57aa3-4399-46c9-9292-567d2a09df4f	2
859421	CRESTOR 40 MG Oral Tablet	PSN	3ec57aa3-4399-46c9-9292-567d2a09df4f	2
859747	rosuvastatin calcium 10 MG Oral Tablet	PSN	3ec57aa3-4399-46c9-9292-567d2a09df4f	2
859751	rosuvastatin calcium 20 MG Oral Tablet	PSN	3ec57aa3-4399-46c9-9292-567d2a09df4f	2
859419	rosuvastatin calcium 40 MG Oral Tablet	PSN	3ec57aa3-4399-46c9-9292-567d2a09df4f	2
859749	rosuvastatin calcium 10 MG Oral Tablet [Crestor]	SBD	3ec57aa3-4399-46c9-9292-567d2a09df4f	2
859753	rosuvastatin calcium 20 MG Oral Tablet [Crestor]	SBD	3ec57aa3-4399-46c9-9292-567d2a09df4f	2
859421	rosuvastatin calcium 40 MG Oral Tablet [Crestor]	SBD	3ec57aa3-4399-46c9-9292-567d2a09df4f	2
859747	rosuvastatin calcium 10 MG Oral Tablet	SCD	3ec57aa3-4399-46c9-9292-567d2a09df4f	2
859751	rosuvastatin calcium 20 MG Oral Tablet	SCD	3ec57aa3-4399-46c9-9292-567d2a09df4f	2
859419	rosuvastatin calcium 40 MG Oral Tablet	SCD	3ec57aa3-4399-46c9-9292-567d2a09df4f	2
859749	Crestor 10 MG Oral Tablet	SY	3ec57aa3-4399-46c9-9292-567d2a09df4f	2
859753	Crestor 20 MG Oral Tablet	SY	3ec57aa3-4399-46c9-9292-567d2a09df4f	2
859421	Crestor 40 MG Oral Tablet	SY	3ec57aa3-4399-46c9-9292-567d2a09df4f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-031-15	43353003115	15 in 1 BOTTLE, PLASTIC	Historical
43353-031-45	43353003145	45 in 1 BOTTLE, PLASTIC	Historical
43353-031-60	43353003160	90 in 1 BOTTLE, PLASTIC	Historical
43353-031-82	43353003182	1200 in 1 BOTTLE, PLASTIC	Historical
43353-031-91	43353003191	1260 in 1 BOTTLE, PLASTIC	Historical
43353-031-99	43353003199	600 in 1 BOTTLE, PLASTIC	Historical