Rosuvastatin Calcium

Product NDC: 43547-593
11-digit product format: 435470593
Labeler code: 43547
Product ID: 43547-593_ab55fc1d-c567-40bc-acbf-089c5a0cc091
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rosuvastatin calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Solco Healthcare LLC
Application: ANDA212059
Marketing category: ANDA
Marketing start: 2021-03-10
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: 2022-12-31
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	43547-593		D	Discontinued by firm	2026-10-05
excluded package	package	43547-593	43547-593-09	D	Discontinued by firm	2026-10-05
excluded package	package	43547-593	43547-593-50	D	Discontinued by firm	2026-10-05

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 · 27 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	43547-593-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43547-593-09	`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	43547-593-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43547-593-09	`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	43547-593-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43547-593-09	`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	43547-593-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43547-593-09	`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	43547-593-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43547-593-09	`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	43547-593-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43547-593-09	`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	43547-593-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43547-593-09	`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	43547-593-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43547-593-09	`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	43547-593-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43547-593-09	`0efc9e666f02…`	`f202fb6c5f17…`

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
A212059-001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-11-04
A212059-002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-04
A212059-003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-04
A212059-004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212059-001	AB
A212059-002	AB
A212059-003	AB
A212059-004	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 · 164 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	A212059-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212059-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212059-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212059-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212059-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212059-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212059-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212059-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212059-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212059-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212059-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212059-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212059-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212059-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212059-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212059-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212059-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212059-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212059-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212059-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212059-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212059-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212059-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212059-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212059-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212059-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212059-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212059-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212059-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212059-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212059-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212059-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212059-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212059-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212059-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212059-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212059-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212059-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212059-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212059-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-11-04	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 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	A212059-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212059-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212059-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212059-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212059-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212059-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212059-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212059-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212059-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212059-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212059-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212059-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212059-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212059-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212059-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212059-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212059-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212059-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212059-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212059-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212059-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212059-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212059-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212059-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212059-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212059-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212059-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212059-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212059-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212059-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212059-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212059-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212059-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212059-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212059-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212059-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212059-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212059-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212059-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212059-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43547-593-09	EA - Each	43547-593	4cdc55cf-6c31-4f93-88d5-15dffaf76056	1	2021-04-08
43547-593-50	EA - Each	43547-593	1b81f1a3-1ae2-4c34-83b4-bc84063fa980	1	2021-04-08

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Zhejiang Yongtai Pharmaceutical Co., Ltd.	40c2900e-4659-49ce-ba4b-5df529b3c53b	2026-07-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212059 application number: ANDA212059

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	Marketing end	Sample	Exclude flag	Status
43547-593-09	43547059309	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-593-09)	2021-03-10	0000-00-00	No	No	Current
43547-593-50	43547059350	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-593-50)	2021-03-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rosuvastatin Calcium	Solco Healthcare LLC \| Zhejiang Yongtai Pharmaceutical Co., Ltd.	2021-03-10	HUMAN PRESCRIPTION DRUG LABEL	3