Rosuvastatin

Product NDC: 55700-575
11-digit product format: 557000575
Labeler code: 55700
Product ID: 55700-575_695e5654-9223-49aa-bfb2-4ff3370b0acf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rosuvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA207616
Marketing category: ANDA
Marketing start: 2018-01-05
Marketing end: 0000-00-00
Substance: ROSUVASTATIN CALCIUM
Active strength: 20 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55700-575		D	Discontinued by firm	2026-08-17
excluded package	package	55700-575	55700-575-30	D	Discontinued by firm	2026-08-17
excluded package	package	55700-575	55700-575-90	D	Discontinued by firm	2026-08-17

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	Approval date
A207616-001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31
A207616-002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31
A207616-003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31
A207616-004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207616-001	AB
A207616-002	AB
A207616-003	AB
A207616-004	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 · 168 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
2026-08-18 06:07:40	2026-07	A207616-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207616-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207616-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207616-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207616-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207616-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207616-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207616-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207616-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207616-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207616-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207616-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207616-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207616-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207616-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207616-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207616-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207616-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207616-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207616-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207616-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207616-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207616-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207616-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207616-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207616-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207616-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207616-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207616-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207616-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207616-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207616-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207616-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207616-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207616-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207616-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207616-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207616-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207616-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207616-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`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	A207616-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207616-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207616-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207616-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207616-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207616-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207616-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207616-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207616-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207616-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207616-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207616-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207616-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207616-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207616-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207616-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207616-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207616-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207616-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207616-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207616-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207616-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207616-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207616-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207616-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207616-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207616-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207616-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207616-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207616-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207616-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207616-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207616-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207616-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207616-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207616-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207616-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207616-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207616-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207616-004	AB	1	`d8e5a09893c0…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-575-30	EA - Each	55700-575	9fdc5f30-b119-4bf7-9e2e-0e5385272505	1	2018-02-20
55700-575-90	EA - Each	55700-575	26ffe19f-e30f-4740-8384-444c63502774	1	2024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55700-575	ROSUVASTATIN TABLET, FILM COATED [QUALITY CARE PRODUCTS, LLC]	9	Legacy NDC	20250101_616fd0c5-39c8-4276-9bcd-b045a08d08de.zip

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rosuvastatin	ROSUVASTATIN	Camber Pharmaceuticals, Inc.	7778df5a-82c1-4a86-8867-a3325da025ec	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207616 application number: ANDA207616
Rosuvastatin	ROSUVASTATIN	Cardinal Health 107, LLC	0f7fad2c-fc46-4ebc-b55b-6534da99e053	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207616 application number: ANDA207616
Rosuvastatin	ROSUVASTATIN	Bryant Ranch Prepack	e6b86b67-62c7-43cc-8174-b2b8e0a60711	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207616 application number: ANDA207616
Rosuvastatin	ROSUVASTATIN	Preferred Pharmaceuticals Inc.	979588e5-d266-4728-aa58-36cd6a217584	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207616 application number: ANDA207616
Rosuvastatin	ROSUVASTATIN	Preferred Pharmaceuticals Inc.	92a58577-b549-4143-abd0-391a07ed714d	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207616 application number: ANDA207616
Rosuvastatin	ROSUVASTATIN	AvPAK	7cd6ae8d-aa67-60db-e053-2991aa0a0ede	2025-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207616 application number: ANDA207616
Rosuvastatin	ROSUVASTATIN	Proficient Rx LP	f42139aa-bb38-4791-b41e-cd8f2c922529	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207616 application number: ANDA207616

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
83MVU38M7Q	ROSUVASTATIN CALCIUM	147098-20-2	ROSUVASTATIN CALCIUM
413KH5ZJ73	ROSUVASTATIN	287714-41-4	Rosuvastatin

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-575-30	55700057530	30 TABLET, FILM COATED in 1 BOTTLE (55700-575-30)	2018-01-05	0000-00-00	No	No	Current