CRESTOR

Product NDC: 0310-0752
11-digit product format: 003100752
Labeler code: 0310
Product ID: 0310-0752_d9298e4d-e35f-4ba4-9fdf-1a8d0358707f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rosuvastatin calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AstraZeneca Pharmaceuticals LP
Application: NDA021366
Marketing category: NDA
Marketing start: 2003-08-18
Marketing end: 2024-04-30
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: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0310-0752		D	Discontinued by firm	2026-08-17
excluded package	package	0310-0752	0310-0752-39	D	Discontinued by firm	2026-08-17
excluded package	package	0310-0752	0310-0752-90	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 1 · 36 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	0310-0752-39	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0310-0752-90	`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	0310-0752-39	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0310-0752-90	`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	0310-0752-39	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0310-0752-90	`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	0310-0752-39	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0310-0752-90	`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	0310-0752-39	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0310-0752-90	`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	0310-0752-39	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0310-0752-90	`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	0310-0752-39	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0310-0752-90	`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	0310-0752-39	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0310-0752-90	`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	0310-0752-39	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0310-0752-90	`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	0310-0752-39	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0310-0752-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0310-0752-39	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0310-0752-90	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0310-0752-39	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0310-0752-90	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0310-0752-39	EA - Each	0310-0752	45a0f4d3-8b33-4ab3-8bac-ce13b4a2c42e	1	2012-07-24
0310-0752-90	EA - Each	0310-0752	b404a801-323c-4b1b-8e31-4c7bf42ecc1e	1	2012-07-24

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 [ASTRAZENECA PHARMACEUTICALS LP]	30
ROSUVASTATIN	ACTIVE MOIETY	413KH5ZJ73	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	30
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	30
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	30
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	30
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	30
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	30
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	30
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	30
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	30
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	30
TRIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	91D9GV0Z28	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]	30
ROSUVASTATIN CALCIUM	ACTIVE INGREDIENT	83MVU38M7Q	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	18
ROSUVASTATIN	ACTIVE MOIETY	413KH5ZJ73	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	18
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	18
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	18
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	18
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	18
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	18
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	18
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	18
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	18
TRIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	91D9GV0Z28	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	18
ROSUVASTATIN CALCIUM	ACTIVE INGREDIENT	83MVU38M7Q	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
ROSUVASTATIN	ACTIVE MOIETY	413KH5ZJ73	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
TRIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	91D9GV0Z28	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
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
ROSUVASTATIN CALCIUM	ACTIVE INGREDIENT	83MVU38M7Q	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
ROSUVASTATIN CALCIUM	ACTIVE INGREDIENT	83MVU38M7Q	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
ROSUVASTATIN	ACTIVE MOIETY	413KH5ZJ73	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
ROSUVASTATIN CALCIUM	ACTIVE MOIETY	83MVU38M7Q	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
TRIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	91D9GV0Z28	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
TRIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	91D9GV0Z28	CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

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

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	ab9f816e-df48-4d90-b8ca-98477659531a	3
859753	CRESTOR 20 MG Oral Tablet	PSN	ab9f816e-df48-4d90-b8ca-98477659531a	3
859421	CRESTOR 40 MG Oral Tablet	PSN	ab9f816e-df48-4d90-b8ca-98477659531a	3
859426	CRESTOR 5 MG Oral Tablet	PSN	ab9f816e-df48-4d90-b8ca-98477659531a	3
859747	rosuvastatin calcium 10 MG Oral Tablet	PSN	ab9f816e-df48-4d90-b8ca-98477659531a	3
859751	rosuvastatin calcium 20 MG Oral Tablet	PSN	ab9f816e-df48-4d90-b8ca-98477659531a	3
859419	rosuvastatin calcium 40 MG Oral Tablet	PSN	ab9f816e-df48-4d90-b8ca-98477659531a	3
859424	rosuvastatin calcium 5 MG Oral Tablet	PSN	ab9f816e-df48-4d90-b8ca-98477659531a	3
859749	rosuvastatin calcium 10 MG Oral Tablet [Crestor]	SBD	ab9f816e-df48-4d90-b8ca-98477659531a	3
859753	rosuvastatin calcium 20 MG Oral Tablet [Crestor]	SBD	ab9f816e-df48-4d90-b8ca-98477659531a	3
859421	rosuvastatin calcium 40 MG Oral Tablet [Crestor]	SBD	ab9f816e-df48-4d90-b8ca-98477659531a	3
859426	rosuvastatin calcium 5 MG Oral Tablet [Crestor]	SBD	ab9f816e-df48-4d90-b8ca-98477659531a	3
859747	rosuvastatin calcium 10 MG Oral Tablet	SCD	ab9f816e-df48-4d90-b8ca-98477659531a	3
859751	rosuvastatin calcium 20 MG Oral Tablet	SCD	ab9f816e-df48-4d90-b8ca-98477659531a	3
859419	rosuvastatin calcium 40 MG Oral Tablet	SCD	ab9f816e-df48-4d90-b8ca-98477659531a	3
859424	rosuvastatin calcium 5 MG Oral Tablet	SCD	ab9f816e-df48-4d90-b8ca-98477659531a	3
859749	Crestor 10 MG Oral Tablet	SY	ab9f816e-df48-4d90-b8ca-98477659531a	3
859753	Crestor 20 MG Oral Tablet	SY	ab9f816e-df48-4d90-b8ca-98477659531a	3
859421	Crestor 40 MG Oral Tablet	SY	ab9f816e-df48-4d90-b8ca-98477659531a	3
859426	Crestor 5 MG Oral Tablet	SY	ab9f816e-df48-4d90-b8ca-98477659531a	3
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
859749	CRESTOR 10 MG Oral Tablet	PSN	3bf80420-7482-44c0-a117-30793ba89544	1
859753	CRESTOR 20 MG Oral Tablet	PSN	4f2f91bb-f119-4e29-8499-f36f436707b3	1
859753	CRESTOR 20 MG Oral Tablet	PSN	3bf80420-7482-44c0-a117-30793ba89544	1
859753	CRESTOR 20 MG Oral Tablet	PSN	598ecc9c-bfd4-4247-a2c3-bd0ce5aa20d0	1
859421	CRESTOR 40 MG Oral Tablet	PSN	3bf80420-7482-44c0-a117-30793ba89544	1
859426	CRESTOR 5 MG Oral Tablet	PSN	3bf80420-7482-44c0-a117-30793ba89544	1
859747	rosuvastatin calcium 10 MG Oral Tablet	PSN	3bf80420-7482-44c0-a117-30793ba89544	1
859751	rosuvastatin calcium 20 MG Oral Tablet	PSN	4f2f91bb-f119-4e29-8499-f36f436707b3	1
859751	rosuvastatin calcium 20 MG Oral Tablet	PSN	3bf80420-7482-44c0-a117-30793ba89544	1
859751	rosuvastatin calcium 20 MG Oral Tablet	PSN	598ecc9c-bfd4-4247-a2c3-bd0ce5aa20d0	1
859419	rosuvastatin calcium 40 MG Oral Tablet	PSN	3bf80420-7482-44c0-a117-30793ba89544	1
859424	rosuvastatin calcium 5 MG Oral Tablet	PSN	3bf80420-7482-44c0-a117-30793ba89544	1
859749	rosuvastatin calcium 10 MG Oral Tablet [Crestor]	SBD	3bf80420-7482-44c0-a117-30793ba89544	1
859753	rosuvastatin calcium 20 MG Oral Tablet [Crestor]	SBD	4f2f91bb-f119-4e29-8499-f36f436707b3	1
859753	rosuvastatin calcium 20 MG Oral Tablet [Crestor]	SBD	598ecc9c-bfd4-4247-a2c3-bd0ce5aa20d0	1
859753	rosuvastatin calcium 20 MG Oral Tablet [Crestor]	SBD	3bf80420-7482-44c0-a117-30793ba89544	1
859421	rosuvastatin calcium 40 MG Oral Tablet [Crestor]	SBD	3bf80420-7482-44c0-a117-30793ba89544	1
859426	rosuvastatin calcium 5 MG Oral Tablet [Crestor]	SBD	3bf80420-7482-44c0-a117-30793ba89544	1
859747	rosuvastatin calcium 10 MG Oral Tablet	SCD	3bf80420-7482-44c0-a117-30793ba89544	1
859751	rosuvastatin calcium 20 MG Oral Tablet	SCD	598ecc9c-bfd4-4247-a2c3-bd0ce5aa20d0	1
859751	rosuvastatin calcium 20 MG Oral Tablet	SCD	4f2f91bb-f119-4e29-8499-f36f436707b3	1
859751	rosuvastatin calcium 20 MG Oral Tablet	SCD	3bf80420-7482-44c0-a117-30793ba89544	1
859419	rosuvastatin calcium 40 MG Oral Tablet	SCD	3bf80420-7482-44c0-a117-30793ba89544	1
859424	rosuvastatin calcium 5 MG Oral Tablet	SCD	3bf80420-7482-44c0-a117-30793ba89544	1
859749	Crestor 10 MG Oral Tablet	SY	3bf80420-7482-44c0-a117-30793ba89544	1
859753	Crestor 20 MG Oral Tablet	SY	3bf80420-7482-44c0-a117-30793ba89544	1
859753	Crestor 20 MG Oral Tablet	SY	598ecc9c-bfd4-4247-a2c3-bd0ce5aa20d0	1
859753	Crestor 20 MG Oral Tablet	SY	4f2f91bb-f119-4e29-8499-f36f436707b3	1
859421	Crestor 40 MG Oral Tablet	SY	3bf80420-7482-44c0-a117-30793ba89544	1
859426	Crestor 5 MG Oral Tablet	SY	3bf80420-7482-44c0-a117-30793ba89544	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0310-0752-90	00310075290	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-0752-90)	2003-08-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CRESTOR	AstraZeneca Pharmaceuticals LP \| AstraZeneca PLC	2023-07-27	HUMAN PRESCRIPTION DRUG LABEL	46
CRESTOR	PD-Rx Pharmaceuticals, Inc.	2022-03-21	HUMAN PRESCRIPTION DRUG LABEL	42
CRESTOR	Bryant Ranch Prepack	2021-11-22	HUMAN PRESCRIPTION DRUG LABEL	10
CRESTOR	REMEDYREPACK INC.	2019-02-25	HUMAN PRESCRIPTION DRUG LABEL	1
CRESTOR	A-S Medication Solutions	2017-11-28	HUMAN PRESCRIPTION DRUG LABEL	3
CRESTOR	Avera McKennan Hospital	2017-03-24	HUMAN PRESCRIPTION DRUG LABEL	1
CRESTOR	Aphena Pharma Solutions - Tennessee, LLC	2014-03-31	HUMAN PRESCRIPTION DRUG LABEL	2
CRESTOR	Physicians Total Care, Inc.	2012-02-01	HUMAN PRESCRIPTION DRUG LABEL	3
CRESTOR	H.J. Harkins Company, Inc. \| AstraZeneca PLC \| IPR Pharmaceuticals, Inc \| AstraZeneca Pharmaceuticals LP \| AstraZeneca UK Ltd. Avlon Works \| Corden Pharma GmbH	2011-11-02	HUMAN PRESCRIPTION DRUG LABEL	1
Crestor - Rebel Distributors Corp	Rebel Distributors Corp	2010-12-09	HUMAN PRESCRIPTION DRUG LABEL	1