Rosuvastatin Calcium

Product NDC: 60290-044
11-digit product format: 602900044
Labeler code: 60290
Product ID: 60290-044_4b2de301-734e-64eb-e063-6394a90a5b91
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rosuvastatin Calcium
Dosage form: TABLET
Route: ORAL
Labeler: Umedica Laboratories USA Inc.
Application: ANDA207626
Marketing category: ANDA
Marketing start: 2025-11-30
Substance: ROSUVASTATIN CALCIUM
Active strength: 10 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 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
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.

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	A207626-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207626-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207626-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207626-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207626-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207626-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207626-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207626-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207626-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207626-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207626-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207626-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207626-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207626-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207626-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207626-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207626-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207626-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207626-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207626-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207626-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207626-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207626-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207626-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207626-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207626-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207626-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207626-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207626-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207626-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207626-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207626-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207626-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207626-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207626-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207626-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207626-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207626-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207626-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207626-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-09	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 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	A207626-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207626-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207626-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207626-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207626-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207626-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207626-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207626-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207626-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207626-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207626-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207626-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207626-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207626-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207626-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207626-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207626-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207626-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207626-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207626-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207626-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207626-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207626-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207626-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207626-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207626-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207626-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207626-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207626-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207626-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207626-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207626-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207626-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207626-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207626-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207626-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207626-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207626-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207626-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207626-004	AB	1	`d8e5a09893c0…`

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	10 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
989dffcf-0254-439d-9f3f-3b0e9d32de0a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
c8f25656-847a-4de8-96a7-06bf98d83c2b	Product name	1	20210916
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
b6a872b4-e31a-fff0-6f62-fd0253265e2f	Product name	9	20190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5	Product name	1	20190429
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60290-044-01	Rosuvastatin Calcium	30 in 1 BOTTLE	TABLET	30	13
60290-044-02	Rosuvastatin Calcium	90 in 1 BOTTLE	TABLET	90	13
60290-044-03	Rosuvastatin Calcium	500 in 1 BOTTLE	TABLET	500	13
60290-044-04	Rosuvastatin Calcium	100 in 1 BLISTER PACK	TABLET	100	13
60290-044-05	Rosuvastatin Calcium	1000 in 1 BOTTLE	TABLET	1000	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60290-044-02	EA - Each	60290-044	8fcee9d9-b5fd-402f-9f20-a8e6a13a8308	1	2026-05-22
60290-044-03	EA - Each	60290-044	2b78a8a6-7cbb-4b87-be28-415084dd0d00	1	2026-05-22
60290-044-05	EA - Each	60290-044	9d1e7336-4666-470b-bf31-b63b5699e868	1	2026-05-22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60290-044	ROSUVASTATIN CALCIUM TABLET [UMEDICA LABORATORIES PRIVATE LIMITED]	7	Current NDC, 5 package rows	20250313_989dffcf-0254-439d-9f3f-3b0e9d32de0a.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	23cc6801-f296-494e-b737-6d7c6df092c3	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207626 application number: ANDA207626
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
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 ndc (product): 60290-044
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

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	989dffcf-0254-439d-9f3f-3b0e9d32de0a	13
859751	rosuvastatin calcium 20 MG Oral Tablet	PSN	989dffcf-0254-439d-9f3f-3b0e9d32de0a	13
859419	rosuvastatin calcium 40 MG Oral Tablet	PSN	989dffcf-0254-439d-9f3f-3b0e9d32de0a	13
859424	rosuvastatin calcium 5 MG Oral Tablet	PSN	989dffcf-0254-439d-9f3f-3b0e9d32de0a	13
859747	rosuvastatin calcium 10 MG Oral Tablet	SCD	989dffcf-0254-439d-9f3f-3b0e9d32de0a	13
859751	rosuvastatin calcium 20 MG Oral Tablet	SCD	989dffcf-0254-439d-9f3f-3b0e9d32de0a	13
859419	rosuvastatin calcium 40 MG Oral Tablet	SCD	989dffcf-0254-439d-9f3f-3b0e9d32de0a	13
859424	rosuvastatin calcium 5 MG Oral Tablet	SCD	989dffcf-0254-439d-9f3f-3b0e9d32de0a	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60290-044-01	60290004401	30 TABLET in 1 BOTTLE (60290-044-01)	30 tablet	2026-02-15	No	No	Current
60290-044-02	60290004402	90 TABLET in 1 BOTTLE (60290-044-02)	90 tablet	2025-11-30	No	No	Current
60290-044-03	60290004403	500 TABLET in 1 BOTTLE (60290-044-03)	500 tablet	2025-11-30	No	No	Current
60290-044-04	60290004404	100 TABLET in 1 BLISTER PACK (60290-044-04)	100 tablet	2026-02-15	No	No	Current
60290-044-05	60290004405	1000 TABLET in 1 BOTTLE (60290-044-05)	1000 tablet	2025-11-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rosuvastatin Calcium	Umedica Laboratories USA Inc. \| UMEDICA LABORATORIES PRIVATE LIMITED	2026-06-04	HUMAN PRESCRIPTION DRUG LABEL	14