Rosuvastatin

Product NDC: 50228-117
Requested package NDC: 50228-117-90
11-digit product format: 502280117
Labeler code: 50228
Product ID: 50228-117_2fb0db87-33a8-e6a1-e063-6294a90a5b4a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rosuvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: ScieGen Pharmaceuticals, Inc.
Application: ANDA206381
Marketing category: ANDA
Marketing start: 2019-04-24
Substance: ROSUVASTATIN
Active strength: 10 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
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 · 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
2026-02-19 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…`
2024-10-29 15:01 UTC	2024-10	A206381-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206381-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206381-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206381-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 112 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-10-29 15:01 UTC	2024-10	A206381-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206381-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206381-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206381-004	AB	1	`d06236e962d9…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ROSUVASTATIN	10 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 · 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
ee4933c5-0d97-494d-ac0f-2083e0100836	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
50228-117-05	Rosuvastatin	500 in 1 BOTTLE	TABLET, FILM COATED	500	9
50228-117-10	Rosuvastatin	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	9
50228-117-30	Rosuvastatin	30 in 1 BOTTLE	TABLET, FILM COATED	30	9
50228-117-90	Rosuvastatin	90 in 1 BOTTLE	TABLET, FILM COATED	90	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50228-117-05	EA - Each	50228-117	07b6a8f6-9630-4f7e-851c-96265fd9653d	1	2024-02-14
50228-117-10	EA - Each	50228-117	e63c2841-21e2-40b1-ab22-5c83c81b4bfa	1	2024-02-14
50228-117-90	EA - Each	50228-117	36d928d6-c6cb-4aff-a842-a766068456a6	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50228-117	ROSUVASTATIN TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.]	9	Current NDC, Legacy NDC, 4 package rows	20250309_ee4933c5-0d97-494d-ac0f-2083e0100836.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 ndc (package): 50228-117-90 ndc (product): 50228-117 ndc11 (package): 50228011790
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
859747	rosuvastatin calcium 10 MG Oral Tablet	PSN	ee4933c5-0d97-494d-ac0f-2083e0100836	9
859751	rosuvastatin calcium 20 MG Oral Tablet	PSN	ee4933c5-0d97-494d-ac0f-2083e0100836	9
859419	rosuvastatin calcium 40 MG Oral Tablet	PSN	ee4933c5-0d97-494d-ac0f-2083e0100836	9
859424	rosuvastatin calcium 5 MG Oral Tablet	PSN	ee4933c5-0d97-494d-ac0f-2083e0100836	9
859747	rosuvastatin calcium 10 MG Oral Tablet	SCD	ee4933c5-0d97-494d-ac0f-2083e0100836	9
859751	rosuvastatin calcium 20 MG Oral Tablet	SCD	ee4933c5-0d97-494d-ac0f-2083e0100836	9
859419	rosuvastatin calcium 40 MG Oral Tablet	SCD	ee4933c5-0d97-494d-ac0f-2083e0100836	9
859424	rosuvastatin calcium 5 MG Oral Tablet	SCD	ee4933c5-0d97-494d-ac0f-2083e0100836	9
859747	rosuvastatin calcium 10 MG Oral Tablet	PSN	b8b29392-85fa-417b-bd10-10ab0d07381f	5
859747	rosuvastatin calcium 10 MG Oral Tablet	SCD	b8b29392-85fa-417b-bd10-10ab0d07381f	5
859747	rosuvastatin calcium 10 MG Oral Tablet	PSN	3153ba21-6314-4d1c-a8f1-9ae7a99c2a1a	4
859747	rosuvastatin calcium 10 MG Oral Tablet	SCD	3153ba21-6314-4d1c-a8f1-9ae7a99c2a1a	4
859747	rosuvastatin calcium 10 MG Oral Tablet	PSN	0f02c184-49f3-8fa6-e063-6394a90a5092	3
859747	rosuvastatin calcium 10 MG Oral Tablet	PSN	adf5df0d-a2e8-4c75-b8fd-15351f4223e9	3
859751	rosuvastatin calcium 20 MG Oral Tablet	PSN	0f02c184-49f3-8fa6-e063-6394a90a5092	3
859419	rosuvastatin calcium 40 MG Oral Tablet	PSN	0f02c184-49f3-8fa6-e063-6394a90a5092	3
859424	rosuvastatin calcium 5 MG Oral Tablet	PSN	0f02c184-49f3-8fa6-e063-6394a90a5092	3
859747	rosuvastatin calcium 10 MG Oral Tablet	SCD	adf5df0d-a2e8-4c75-b8fd-15351f4223e9	3
859747	rosuvastatin calcium 10 MG Oral Tablet	SCD	0f02c184-49f3-8fa6-e063-6394a90a5092	3
859751	rosuvastatin calcium 20 MG Oral Tablet	SCD	0f02c184-49f3-8fa6-e063-6394a90a5092	3
859419	rosuvastatin calcium 40 MG Oral Tablet	SCD	0f02c184-49f3-8fa6-e063-6394a90a5092	3
859424	rosuvastatin calcium 5 MG Oral Tablet	SCD	0f02c184-49f3-8fa6-e063-6394a90a5092	3
859747	rosuvastatin calcium 10 MG Oral Tablet	PSN	d4396def-5692-48ef-b3ab-f0ab2baadf27	1
859747	rosuvastatin calcium 10 MG Oral Tablet	PSN	e7955483-fecd-4376-b177-c669f862a3ac	1
859747	rosuvastatin calcium 10 MG Oral Tablet	PSN	26d14bab-ee7c-49fe-9fb0-8426a589b599	1
859747	rosuvastatin calcium 10 MG Oral Tablet	PSN	46173656-d889-ec14-e063-6294a90aae81	1
859424	rosuvastatin calcium 5 MG Oral Tablet	PSN	d4396def-5692-48ef-b3ab-f0ab2baadf27	1
859747	rosuvastatin calcium 10 MG Oral Tablet	SCD	d4396def-5692-48ef-b3ab-f0ab2baadf27	1
859747	rosuvastatin calcium 10 MG Oral Tablet	SCD	e7955483-fecd-4376-b177-c669f862a3ac	1
859747	rosuvastatin calcium 10 MG Oral Tablet	SCD	46173656-d889-ec14-e063-6294a90aae81	1
859747	rosuvastatin calcium 10 MG Oral Tablet	SCD	26d14bab-ee7c-49fe-9fb0-8426a589b599	1
859424	rosuvastatin calcium 5 MG Oral Tablet	SCD	d4396def-5692-48ef-b3ab-f0ab2baadf27	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50228-117-90	50228011790	90 TABLET, FILM COATED in 1 BOTTLE (50228-117-90)	2019-04-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rosuvastatin	Coupler LLC	2025-12-16	HUMAN PRESCRIPTION DRUG LABEL	1
Rosuvastatin	Preferred Pharmaceuticals Inc.	2025-11-24	HUMAN PRESCRIPTION DRUG LABEL	1
Rosuvastatin	A-S Medication Solutions	2025-10-10	HUMAN PRESCRIPTION DRUG LABEL	4
Rosuvastatin	A-S Medication Solutions	2025-10-10	HUMAN PRESCRIPTION DRUG LABEL	3
Rosuvastatin	REMEDYREPACK INC.	2025-07-14	HUMAN PRESCRIPTION DRUG LABEL	5
Rosuvastatin	Golden State Medical Supply, Inc.	2025-04-15	HUMAN PRESCRIPTION DRUG LABEL	3
Rosuvastatin	ScieGen Pharmaceuticals, Inc.	2025-02-25	HUMAN PRESCRIPTION DRUG LABEL	9
Rosuvastatin	Bryant Ranch Prepack	2024-12-10	HUMAN PRESCRIPTION DRUG LABEL	1
Rosuvastatin	ATLANTIC BIOLOGICALS CORP	2024-11-25	HUMAN PRESCRIPTION DRUG LABEL	1