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	2026-10-15
excluded package	package	0310-0752	0310-0752-39	D	Discontinued by firm	2026-10-15
excluded package	package	0310-0752	0310-0752-90	D	Discontinued by firm	2026-10-15

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 44.

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 · 176 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
2026-10-15 13:18:30	2026-09	N021366-002	CRESTOR	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021366-003	CRESTOR	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021366-004	CRESTOR	EQ 20MG BASE	TABLET / ORAL	AB	RLD	2003-08-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021366-005	CRESTOR	EQ 40MG BASE	TABLET / ORAL	AB	RLD, RS	2003-08-12	`c2088c7a36db…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
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…`

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

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

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