Rosuvastatin Calcium

Product NDC: 67296-2289
Requested package NDC: 67296-2289-9
11-digit product format: 672962289
Labeler code: 67296
Product ID: 67296-2289_57d226fb-75c3-ce9b-e063-6394a90aa950
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rosuvastatin Calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Redpharm Drug
Application: ANDA079172
Marketing category: ANDA
Marketing start: 2019-06-27
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A079172-001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19
A079172-002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19
A079172-003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19
A079172-004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079172-001	AB
A079172-002	AB
A079172-003	AB
A079172-004	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A079172-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079172-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079172-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079172-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079172-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079172-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079172-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079172-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079172-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079172-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079172-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079172-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079172-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079172-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079172-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079172-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079172-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079172-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079172-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079172-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079172-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079172-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079172-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079172-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079172-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079172-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079172-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079172-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079172-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079172-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079172-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079172-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079172-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079172-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079172-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079172-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079172-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079172-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079172-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079172-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A079172-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079172-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079172-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079172-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079172-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079172-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079172-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079172-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079172-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079172-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079172-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079172-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079172-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079172-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079172-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079172-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079172-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079172-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079172-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079172-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079172-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079172-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079172-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079172-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079172-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079172-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079172-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079172-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079172-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079172-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079172-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079172-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079172-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079172-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079172-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079172-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079172-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079172-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079172-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079172-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Rosuvastatin Calcium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ROSUVASTATIN CALCIUM	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
83MVU38M7Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
859751	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
57d226e7-30f4-cecb-e063-6394a90a692f	Available on FDA.report

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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	REMEDYREPACK INC.	c607da3c-47f5-4773-8391-2a7b0826d30e	2026-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079172 application number: ANDA079172
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	REMEDYREPACK INC.	f230f4fe-0dbd-4062-9e11-a3e74bcdcba8	2026-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079172 application number: ANDA079172
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	REMEDYREPACK INC.	94245f53-2892-4209-8c94-c32c87d5b106	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079172 application number: ANDA079172
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Preferred Pharmaceuticals Inc.,	e432e043-c019-4d58-94ca-7c1d85f5cd40	2026-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079172 application number: ANDA079172
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Glenmark Pharmaceutials Inc., USA	392657a9-955c-42c2-814c-1890ece45afa	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079172 application number: ANDA079172
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Redpharm Drug	57d1fb5b-1b85-7dd9-e063-6394a90a3fb1	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079172 application number: ANDA079172
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Redpharm Drug	57d226e7-30f4-cecb-e063-6394a90a692f	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079172 application number: ANDA079172 ndc (package): 67296-2289-9 ndc (product): 67296-2289 ndc11 (package): 67296228909
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	76568df9-1a56-4e23-ac84-28f3b72cc242	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079172 application number: ANDA079172
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	82308a25-97e8-44ba-a6c4-d6e03d08cd6a	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079172 application number: ANDA079172
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	QPharma, Inc.	4148e0b3-0340-9f3a-e063-6394a90afc96	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079172 application number: ANDA079172
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	8bd56c80-2f98-4b6e-809e-d0e981c3dcb3	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079172 application number: ANDA079172
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Northwind Health Company, LLC	f80b8d59-2c22-8fff-e053-6294a90a2f9e	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079172 application number: ANDA079172
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Northwind Health Company, LLC	1d86f10c-1e47-cefc-e063-6394a90a9f2e	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079172 application number: ANDA079172
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Northwind Health Company, LLC	f80c5f1e-6a36-4b76-e053-6394a90a681d	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079172 application number: ANDA079172
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	3493b809-74b0-71b0-e063-6294a90a9a99	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079172 application number: ANDA079172
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NorthStar RxLLC	17d71c80-fade-4735-acec-60738d26dd01	2025-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079172 application number: ANDA079172
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	45033c5f-4246-491a-8707-10f840ff2b6c	2025-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079172 application number: ANDA079172
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	3b556f65-fae9-436f-9cc5-3160d1c9b18a	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079172 application number: ANDA079172
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	e5decd64-cde1-4d8d-9853-7243fb0e1722	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079172 application number: ANDA079172
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	f07922e5-a963-4ecf-86db-c1ae12f85224	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079172 application number: ANDA079172

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
67296-2289-9	67296228909	90 TABLET, FILM COATED in 1 BOTTLE (67296-2289-9)	2019-06-27	No	No	Current