Rosuvastatin Calcium

Product NDC: 72603-366
Requested package NDC: 72603-366-02
11-digit product format: 726030366
Labeler code: 72603
Product ID: 72603-366_4687569b-7762-fb06-e063-6294a90aadc7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rosuvastatin Calcium
Dosage form: TABLET
Route: ORAL
Labeler: NorthStar Rx, LLC
Application: ANDA207626
Marketing category: ANDA
Marketing start: 2025-12-15
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A207626-001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-09
A207626-002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-09
A207626-003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-09
A207626-004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207626-001	AB
A207626-002	AB
A207626-003	AB
A207626-004	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A207626-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A207626-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A207626-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A207626-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A207626-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A207626-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A207626-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A207626-004	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	REMEDYREPACK INC.	0c919fc0-a3d7-4afb-968b-4ef0e447001c	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207626 application number: ANDA207626
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NorthStar Rx, LLC	c622757d-7370-438b-8c2d-ef444a4f31dd	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207626 application number: ANDA207626 ndc (package): 72603-366-02 ndc (product): 72603-366 ndc11 (package): 72603036602
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Umedica Laboratories USA Inc.	989dffcf-0254-439d-9f3f-3b0e9d32de0a	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207626 application number: ANDA207626
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	9d5f8ff6-c622-4101-805d-70bdc888b27e	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207626 application number: ANDA207626
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	5da61cc3-93f3-4d95-ab39-55821484a3bd	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207626 application number: ANDA207626
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	2984f47e-9246-46d0-842e-43c540dd12a5	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207626 application number: ANDA207626
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	2c72feef-6742-4d8a-9515-89be4e430c4f	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207626 application number: ANDA207626
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Preferred Pharmaceuticals Inc.	1346ab60-808b-442b-8217-a59bb9986f03	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207626 application number: ANDA207626
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Preferred Pharmaceuticals Inc.	60d52228-f74f-46eb-85d2-e6b0cbb36092	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207626 application number: ANDA207626
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	TORRENT PHARMACEUTICALS LIMITED	6985e729-d963-4f32-89a1-727472b86daa	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207626 application number: ANDA207626
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Preferred Pharmaceuticals Inc.	1eb971e3-de67-46ae-a8ef-8a7d2805cfdd	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207626 application number: ANDA207626
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	20101145-4c4f-8f0a-e063-6394a90ae27d	2024-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207626 application number: ANDA207626
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	1aca7a86-940b-c6e1-e063-6294a90a5944	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207626 application number: ANDA207626

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
859419	Internal RxNorm lookup
859424	Internal RxNorm lookup
859747	Internal RxNorm lookup
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
c622757d-7370-438b-8c2d-ef444a4f31dd	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72603-366-01	Rosuvastatin Calcium	90 in 1 BOTTLE	TABLET	90	2
72603-366-02	Rosuvastatin Calcium	500 in 1 BOTTLE	TABLET	500	2
72603-366-03	Rosuvastatin Calcium	1000 in 1 BOTTLE	TABLET	1000	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72603-366-01	EA - Each	72603-366	558bb00e-cefd-4135-8da7-a6a1cbd7c400	1	2026-03-17
72603-366-02	EA - Each	72603-366	535505f8-db54-4673-a95e-f6a15f232b85	1	2026-03-17
72603-366-03	EA - Each	72603-366	38b76c5e-19e4-458f-9cc7-5e2593bbe6d2	1	2026-03-17

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
859747	rosuvastatin calcium 10 MG Oral Tablet	PSN	c622757d-7370-438b-8c2d-ef444a4f31dd	2
859751	rosuvastatin calcium 20 MG Oral Tablet	PSN	c622757d-7370-438b-8c2d-ef444a4f31dd	2
859419	rosuvastatin calcium 40 MG Oral Tablet	PSN	c622757d-7370-438b-8c2d-ef444a4f31dd	2
859424	rosuvastatin calcium 5 MG Oral Tablet	PSN	c622757d-7370-438b-8c2d-ef444a4f31dd	2
859747	rosuvastatin calcium 10 MG Oral Tablet	SCD	c622757d-7370-438b-8c2d-ef444a4f31dd	2
859751	rosuvastatin calcium 20 MG Oral Tablet	SCD	c622757d-7370-438b-8c2d-ef444a4f31dd	2
859419	rosuvastatin calcium 40 MG Oral Tablet	SCD	c622757d-7370-438b-8c2d-ef444a4f31dd	2
859424	rosuvastatin calcium 5 MG Oral Tablet	SCD	c622757d-7370-438b-8c2d-ef444a4f31dd	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72603-366-02	72603036602	500 TABLET in 1 BOTTLE (72603-366-02)	500 tablet	2025-12-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rosuvastatin Calcium	NorthStar Rx, LLC \| UMEDICA LABORATORIES PRIVATE LIMITED	2026-06-19	HUMAN PRESCRIPTION DRUG LABEL	3