Rosuvastatin

Product NDC: 71610-798
11-digit product format: 716100798
Labeler code: 71610
Product ID: 71610-798_20253fa4-28cf-2a97-e063-6294a90af9c4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rosuvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA206381
Marketing category: ANDA
Marketing start: 2019-04-24
Substance: ROSUVASTATIN
Active strength: 40 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 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
A206381-001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24
A206381-002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24
A206381-003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24
A206381-004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206381-001	AB
A206381-002	AB
A206381-003	AB
A206381-004	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	A206381-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206381-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206381-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206381-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206381-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206381-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206381-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206381-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206381-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206381-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206381-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206381-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206381-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206381-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206381-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206381-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206381-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206381-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206381-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206381-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206381-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206381-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206381-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206381-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206381-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206381-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206381-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206381-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206381-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206381-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206381-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206381-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206381-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206381-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206381-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206381-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206381-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206381-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206381-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206381-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 116 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	A206381-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206381-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206381-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206381-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206381-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206381-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206381-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206381-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206381-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206381-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206381-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206381-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206381-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206381-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206381-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206381-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206381-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206381-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206381-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206381-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206381-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206381-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206381-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206381-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206381-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206381-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206381-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206381-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206381-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206381-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206381-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206381-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206381-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206381-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206381-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206381-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206381-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206381-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206381-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206381-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Rosuvastatin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ROSUVASTATIN	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
413KH5ZJ73	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
859419	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
1185b112-f59d-8762-e063-6394a90a120d	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
71610-798-15	Rosuvastatin	15 in 1 BOTTLE	TABLET, FILM COATED	15	4
71610-798-16	Rosuvastatin	6000 in 1 BOTTLE	TABLET, FILM COATED	6000	4
71610-798-30	Rosuvastatin	30 in 1 BOTTLE	TABLET, FILM COATED	30	4
71610-798-45	Rosuvastatin	45 in 1 BOTTLE	TABLET, FILM COATED	45	4
71610-798-53	Rosuvastatin	60 in 1 BOTTLE	TABLET, FILM COATED	60	4
71610-798-60	Rosuvastatin	90 in 1 BOTTLE	TABLET, FILM COATED	90	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-798-15	EA - Each	71610-798	68fb254a-8f26-4ec5-a713-28cdace4c118	1	2024-04-05
71610-798-16	EA - Each	71610-798	4a1b11ef-1f55-49c9-b344-80fffd6ae3ad	1	2024-08-12
71610-798-30	EA - Each	71610-798	4ed19267-6ae2-425e-a400-888034d897b8	1	2024-04-05
71610-798-45	EA - Each	71610-798	8b1de6b9-9161-4da9-a09f-b02c54715c47	1	2024-04-05
71610-798-53	EA - Each	71610-798	ead30f8c-e051-4466-84dc-666045fb17a2	1	2024-04-05
71610-798-60	EA - Each	71610-798	ac4f05b5-ae02-4b17-9bbf-46d7cde8a8ef	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-798	ROSUVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]	4	Current NDC, 6 package rows	20240822_1185b112-f59d-8762-e063-6394a90a120d.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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rosuvastatin	ROSUVASTATIN	Preferred Pharmaceuticals Inc.	88fd44de-f2c4-4541-a859-bb9553da9674	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	A-S Medication Solutions	a2ac073e-4d9a-4b0a-8698-a06d73dc6962	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	A-S Medication Solutions	4cbafae0-c316-4f28-8c95-b831cab9a0eb	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	Coupler LLC	46173656-d889-ec14-e063-6294a90aae81	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	A-S Medication Solutions	771d3591-ecca-43de-a0f3-c72adb8543f5	2025-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	Preferred Pharmaceuticals Inc.	26d14bab-ee7c-49fe-9fb0-8426a589b599	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	A-S Medication Solutions	81910817-f976-4936-ae31-d211083d249b	2025-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	A-S Medication Solutions	3153ba21-6314-4d1c-a8f1-9ae7a99c2a1a	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	A-S Medication Solutions	adf5df0d-a2e8-4c75-b8fd-15351f4223e9	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	A-S Medication Solutions	f201a404-9170-4684-a988-0c0aedcd2ddb	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	REMEDYREPACK INC.	6ebaefa9-2c71-4777-8730-83cf5ae737cc	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	Preferred Pharmaceuticals Inc.	d91dd29a-bb29-4193-a849-840f8696f658	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	REMEDYREPACK INC.	a370a6c2-b5cd-4aa0-b072-a5a8017a2d5b	2025-07-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	REMEDYREPACK INC.	b8b29392-85fa-417b-bd10-10ab0d07381f	2025-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	3982830d-3cda-e636-e063-6394a90a1eb1	2025-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	REMEDYREPACK INC.	ab8f6264-cf12-4523-92f1-2bd60b3da442	2025-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	NuCare Pharmaceuticals, Inc.	351ee6c1-3e31-3f87-e063-6394a90a47c7	2025-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	Golden State Medical Supply, Inc.	0f02c184-49f3-8fa6-e063-6394a90a5092	2025-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	ScieGen Pharmaceuticals, Inc.	ee4933c5-0d97-494d-ac0f-2083e0100836	2025-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	A-S Medication Solutions	b7f943f4-35da-4aa7-a4fc-810b914748bf	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
413KH5ZJ73	ROSUVASTATIN	287714-41-4	ROSUVASTATIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
859419	rosuvastatin calcium 40 MG Oral Tablet	PSN	1185b112-f59d-8762-e063-6394a90a120d	4
859419	rosuvastatin calcium 40 MG Oral Tablet	SCD	1185b112-f59d-8762-e063-6394a90a120d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71610-798-15	71610079815	15 TABLET, FILM COATED in 1 BOTTLE (71610-798-15)	2024-02-16	No	No	Current
71610-798-16	71610079816	6000 TABLET, FILM COATED in 1 BOTTLE (71610-798-16)	2024-06-26	No	No	Current
71610-798-30	71610079830	30 TABLET, FILM COATED in 1 BOTTLE (71610-798-30)	2024-02-16	No	No	Current
71610-798-45	71610079845	45 TABLET, FILM COATED in 1 BOTTLE (71610-798-45)	2024-02-16	No	No	Current
71610-798-53	71610079853	60 TABLET, FILM COATED in 1 BOTTLE (71610-798-53)	2024-02-16	No	No	Current
71610-798-60	71610079860	90 TABLET, FILM COATED in 1 BOTTLE (71610-798-60)	2024-02-16	No	No	Current