CRESTOR

Product NDC: 55154-6924
11-digit product format: 551546924
Labeler code: 55154
Product ID: 55154-6924_a9086349-8827-46b6-a17f-e8c61df14a5e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rosuvastatin calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Cardinal Health
Application: NDA021366
Marketing category: NDA
Marketing start: 2010-12-01
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: 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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55154-6924		D	Discontinued by firm	2026-08-17
excluded package	package	55154-6924	55154-6924-0	D	Discontinued by firm	2026-08-17
excluded package	package	55154-6924	55154-6924-2	D	Discontinued by firm	2026-08-17
excluded package	package	55154-6924	55154-6924-7	D	Discontinued by firm	2026-08-17
excluded package	package	55154-6924	55154-6924-8	D	Discontinued by firm	2026-08-17
excluded package	package	55154-6924	55154-6924-9	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 · 72 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	55154-6924-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55154-6924-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55154-6924-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55154-6924-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55154-6924-0	`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	55154-6924-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55154-6924-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55154-6924-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55154-6924-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55154-6924-0	`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	55154-6924-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55154-6924-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55154-6924-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55154-6924-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55154-6924-0	`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	55154-6924-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55154-6924-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55154-6924-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55154-6924-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55154-6924-0	`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	55154-6924-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55154-6924-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55154-6924-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55154-6924-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55154-6924-0	`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	55154-6924-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55154-6924-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55154-6924-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55154-6924-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55154-6924-0	`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	55154-6924-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55154-6924-7	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55154-6924-9	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55154-6924-8	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55154-6924-0	`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	55154-6924-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55154-6924-7	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55154-6924-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55154-6924-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55154-6924-0	`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	55154-6924-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55154-6924-7	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55154-6924-9	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55154-6924-8	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55154-6924-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55154-6924-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55154-6924-7	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55154-6924-9	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55154-6924-8	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55154-6924-0	`ad56d346431e…`	`cc804d4bbf1e…`

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	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 · 168 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
2026-08-18 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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021366-002	CRESTOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021366-003	CRESTOR	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021366-004	CRESTOR	EQ 20MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021366-005	CRESTOR	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	2003-08-12	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021366-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021366-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021366-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021366-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021366-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021366-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021366-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021366-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021366-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021366-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021366-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021366-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021366-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021366-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021366-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021366-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021366-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021366-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021366-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021366-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021366-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021366-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021366-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021366-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021366-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021366-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021366-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021366-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021366-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021366-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021366-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021366-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021366-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021366-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021366-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021366-005	AB	1	`5bbf6a4d5a75…`
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…`

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…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crestor	ROSUVASTATIN	AstraZeneca Pharmaceuticals LP	325a5d0e-9a72-4015-9fcd-1655fb504cee	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021366 application number: NDA021366