Application 021366

Type: NDA
Sponsor: IPR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	CRESTOR	ROSUVASTATIN CALCIUM	TABLET;ORAL	5MG	Yes	No
003	CRESTOR	ROSUVASTATIN CALCIUM	TABLET;ORAL	10MG	Yes	No
004	CRESTOR	ROSUVASTATIN CALCIUM	TABLET;ORAL	20MG	Yes	No
005	CRESTOR	ROSUVASTATIN CALCIUM	TABLET;ORAL	40MG	Yes	Yes

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 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N021366-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021366-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021366-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021366-005	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021366-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021366-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021366-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021366-005	AB	1	`84e616aacf4f…`
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…`

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 2 of 7 · 128 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Torrent Pharmaceuticals Limited	8c2d481f-53f2-4cf6-bd28-7d92323785cd	2026-06-15	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Umedica Laboratories USA Inc.	989dffcf-0254-439d-9f3f-3b0e9d32de0a	2026-06-04	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Shandong New Time Pharmaceutical Co., Ltd.	ae865404-ecf4-41a8-b40b-62f887c220f2	2026-05-27	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	67da041b-7ad5-4309-86b3-8c30a5f9465e	2026-05-27	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM
ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	bf40166a-4f73-47ff-938b-2bdbf7f000e4	2026-05-19	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	9d5f8ff6-c622-4101-805d-70bdc888b27e	2026-05-19	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	76568df9-1a56-4e23-ac84-28f3b72cc242	2026-05-19	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	5da61cc3-93f3-4d95-ab39-55821484a3bd	2026-05-19	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	82308a25-97e8-44ba-a6c4-d6e03d08cd6a	2026-05-19	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	2984f47e-9246-46d0-842e-43c540dd12a5	2026-05-18	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	2c72feef-6742-4d8a-9515-89be4e430c4f	2026-05-18	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	QPharma, Inc.	4148e0b3-0340-9f3a-e063-6394a90afc96	2026-05-12	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	8bd56c80-2f98-4b6e-809e-d0e981c3dcb3	2026-05-01	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	c2d9a04e-8c72-d487-e053-2a95a90a0fcd	2026-03-26	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM
ROSUVASTATIN	ROSUVASTATIN	DIRECT RX	99602058-4681-7cb5-e053-2995a90a099c	2026-03-05	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	be73cea2-f89a-e4c5-e053-2a95a90a9cce	2026-03-02	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Preferred Pharmaceuticals Inc.	1346ab60-808b-442b-8217-a59bb9986f03	2026-02-17	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	275d4288-064d-d1bd-e063-6294a90a28e1	2026-02-05	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Northwind Health Company, LLC	f80b8d59-2c22-8fff-e053-6294a90a2f9e	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Northwind Health Company, LLC	da6bfffb-7b04-b522-e053-2a95a90a4736	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: ROSUVASTATIN CALCIUM

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 81 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-0751	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0751	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0751	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0751	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0751	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0751	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0751	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0752	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0752	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0752	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0752	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0752	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0752	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0752	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0754	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0754	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0754	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0754	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0754	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0754	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0754	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0755	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0755	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0755	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0755	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0755	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0755	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0755	CRESTOR	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-7560	Crestor	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-7570	Crestor	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-7580	Crestor	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-7580	Crestor	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-7580	Crestor	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-7590	Crestor	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-7590	Crestor	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-7590	Crestor	Rosuvastatin calcium	AstraZeneca Pharmaceuticals LP	NDA	Current
21695-287	Crestor	Rosuvastatin calcium	Rebel Distributors Corp	NDA	Current
21695-288	Crestor	Rosuvastatin calcium	Rebel Distributors Corp	NDA	Current
21695-659	Crestor	Rosuvastatin calcium	Rebel Distributors Corp	NDA	Current
21695-759	Crestor	Rosuvastatin calcium	Rebel Distributors Corp	NDA	Current
35356-413	Crestor	Rosuvastatin calcium	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
43353-031	CRESTOR	Rosuvastatin calcium	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
43353-289	CRESTOR	Rosuvastatin calcium	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
43353-290	CRESTOR	Rosuvastatin calcium	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
50090-1097	CRESTOR	Rosuvastatin calcium	A-S Medication Solutions	NDA	Current
50090-1097	CRESTOR	Rosuvastatin calcium	A-S Medication Solutions	NDA	Current
50090-1621	CRESTOR	Rosuvastatin calcium	A-S Medication Solutions	NDA	Current
52959-629	CRESTOR	Rosuvastatin calcium	H.J. Harkins Company, Inc.	NDA	Current
55154-6921	CRESTOR	Rosuvastatin calcium	Cardinal Health	NDA	Current
55154-6924	CRESTOR	Rosuvastatin calcium	Cardinal Health	NDA	Current
55289-932	CRESTOR	Rosuvastatin calcium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-932	CRESTOR	Rosuvastatin calcium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-932	CRESTOR	Rosuvastatin calcium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-932	CRESTOR	Rosuvastatin calcium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-932	CRESTOR	Rosuvastatin calcium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-935	CRESTOR	Rosuvastatin calcium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-935	CRESTOR	Rosuvastatin calcium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-935	CRESTOR	Rosuvastatin calcium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-935	CRESTOR	Rosuvastatin calcium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-935	CRESTOR	Rosuvastatin calcium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
63629-3381	CRESTOR	Rosuvastatin calcium	Bryant Ranch Prepack	NDA	Current
63629-3381	CRESTOR	Rosuvastatin calcium	Bryant Ranch Prepack	NDA	Current
63629-3381	CRESTOR	Rosuvastatin calcium	Bryant Ranch Prepack	NDA	Current
63629-4311	CRESTOR	Rosuvastatin calcium	Bryant Ranch Prepack	NDA	Current
63629-4372	CRESTOR	Rosuvastatin calcium	Bryant Ranch Prepack	NDA	Current
63629-4372	CRESTOR	Rosuvastatin calcium	Bryant Ranch Prepack	NDA	Current
63629-6372	CRESTOR	Rosuvastatin calcium	Bryant Ranch Prepack	NDA	Current
63629-6372	CRESTOR	Rosuvastatin calcium	Bryant Ranch Prepack	NDA	Current
63629-6427	CRESTOR	Rosuvastatin calcium	Bryant Ranch Prepack	NDA	Current
63629-6427	CRESTOR	Rosuvastatin calcium	Bryant Ranch Prepack	NDA	Current
63629-6427	CRESTOR	Rosuvastatin calcium	Bryant Ranch Prepack	NDA	Current
63629-6427	CRESTOR	Rosuvastatin calcium	Bryant Ranch Prepack	NDA	Current
63629-6924	CRESTOR	Rosuvastatin calcium	Bryant Ranch Prepack	NDA	Current
63629-6924	CRESTOR	Rosuvastatin calcium	Bryant Ranch Prepack	NDA	Current
63629-6924	CRESTOR	Rosuvastatin calcium	Bryant Ranch Prepack	NDA	Current
63629-6924	CRESTOR	Rosuvastatin calcium	Bryant Ranch Prepack	NDA	Current
68151-4634	CRESTOR	Rosuvastatin calcium	Carilion Materials Management	NDA	Current
69189-0752	CRESTOR	Rosuvastatin calcium	Avera McKennan Hospital	NDA	Current
70518-1904	CRESTOR	Rosuvastatin calcium	REMEDYREPACK INC.	NDA	Current
70518-1905	CRESTOR	Rosuvastatin calcium	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85782	SUPPL	2026-05-01
83891	SUPPL	2025-11-19
79279	SUPPL	2024-08-02
79264	SUPPL	2024-08-02
74924	SUPPL	2023-07-31
74915	SUPPL	2023-07-28
73227	SUPPL	2023-01-17
73178	SUPPL	2023-01-17
73177	SUPPL	2023-01-17
64729	SUPPL	2020-09-29
64702	SUPPL	2020-09-28
63313	SUPPL	2020-05-28
63312	SUPPL	2020-05-28
63274	SUPPL	2020-05-22
63273	SUPPL	2020-05-22
56451	SUPPL	2018-11-15
56416	SUPPL	2018-11-12
49899	SUPPL	2017-10-01
49270	SUPPL	2017-08-08
36782	SUPPL	2016-06-01
5196	SUPPL	2016-05-31
36780	SUPPL	2015-11-25
27614	SUPPL	2015-11-23
36781	SUPPL	2015-06-04
5195	SUPPL	2015-06-04
36779	SUPPL	2014-08-12
27613	SUPPL	2014-07-10
36778	SUPPL	2013-08-09
15316	SUPPL	2013-08-09
27612	SUPPL	2013-08-08
5194	SUPPL	2013-08-08
27611	SUPPL	2012-12-26
15315	SUPPL	2012-12-21
27610	SUPPL	2012-11-05
5193	SUPPL	2012-11-05
36777	SUPPL	2012-11-02
36776	SUPPL	2012-11-02
21622	SUPPL	2012-03-30
15314	SUPPL	2012-02-28
5192	SUPPL	2012-02-28
23997	SUPPL	2011-12-16
23998	SUPPL	2011-11-01
42122	SUPPL	2011-09-22
27609	SUPPL	2010-11-26
15313	SUPPL	2010-11-26
42123	SUPPL	2010-07-27
24194	SUPPL	2010-07-27
5191	SUPPL	2010-02-12
36774	SUPPL	2010-02-08
27608	SUPPL	2010-01-28
36775	SUPPL	2010-01-24
27607	SUPPL	2009-11-25
15312	SUPPL	2009-10-21
52326	SUPPL	2009-07-07
36773	SUPPL	2009-04-03
27606	SUPPL	2009-04-01
36772	SUPPL	2009-01-29
27605	SUPPL	2009-01-26
27604	SUPPL	2008-11-13
36771	SUPPL	2008-11-07
27603	SUPPL	2007-11-19
36770	SUPPL	2007-11-13
5190	SUPPL	2007-07-27
15311	SUPPL	2007-07-24
27602	SUPPL	2005-03-03
15310	SUPPL	2005-03-02
23651	ORIG	2004-03-24
21621	ORIG	2004-01-29
27601	ORIG	2004-01-20
15309	ORIG	2003-08-14
53073	ORIG	1900-01-01
53072	ORIG	1900-01-01
53071	ORIG	1900-01-01
52890	ORIG	1900-01-01