Rosuvastatin Calcium

Product NDC: 72205-027
11-digit product format: 722050027
Labeler code: 72205
Product ID: 72205-027_62787a4a-6d53-43a3-a0b7-ed0b6037d18e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rosuvastatin Calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Novadoz Pharmaceuticals LLC
Application: ANDA208898
Marketing category: ANDA
Marketing start: 2017-11-22
Substance: ROSUVASTATIN CALCIUM
Active strength: 5 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 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
A208898-001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-11-22
A208898-002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-11-22
A208898-003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-11-22
A208898-004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-11-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208898-001	AB
A208898-002	AB
A208898-003	AB
A208898-004	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 · 172 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	A208898-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-11-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208898-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-11-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208898-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-11-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208898-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-11-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208898-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208898-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208898-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208898-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-11-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208898-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208898-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208898-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208898-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208898-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208898-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208898-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208898-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208898-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208898-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208898-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208898-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208898-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208898-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208898-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208898-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208898-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208898-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208898-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208898-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208898-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208898-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208898-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208898-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208898-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208898-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208898-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208898-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-11-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208898-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208898-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208898-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208898-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-11-22	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A208898-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208898-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208898-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208898-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208898-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208898-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208898-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208898-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208898-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208898-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208898-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208898-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208898-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208898-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208898-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208898-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208898-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208898-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208898-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208898-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208898-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208898-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208898-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208898-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208898-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208898-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208898-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208898-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208898-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208898-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208898-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208898-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208898-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208898-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208898-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208898-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208898-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208898-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208898-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208898-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ROSUVASTATIN CALCIUM	5 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
d58f1f63-4bb6-413c-9730-ded3e8078618	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
b6a872b4-e31a-fff0-6f62-fd0253265e2f	Product name	9	20190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5	Product name	1	20190429
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72205-027-05	Rosuvastatin Calcium	500 in 1 BOTTLE	TABLET, FILM COATED	500	9
72205-027-06	Rosuvastatin Calcium	100 in 1 CARTON	TABLET, FILM COATED	100	9
72205-027-11	Rosuvastatin Calcium	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	9
72205-027-90	Rosuvastatin Calcium	90 in 1 BOTTLE	TABLET, FILM COATED	90	9
72205-027-99	Rosuvastatin Calcium	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72205-027-90	EA - Each	72205-027	e8d0adcb-607b-42ff-8744-a7f4c1d9d531	1	2019-06-19
72205-027-99	EA - Each	72205-027	6407e2a7-63cf-4956-afb0-bd738b90b196	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72205-027	ROSUVASTATIN CALCIUM TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]	9	Current NDC, Legacy NDC, 5 package rows	20250302_d58f1f63-4bb6-413c-9730-ded3e8078618.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 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Preferred Pharmaceuticals, Inc.	6ef51f7c-2899-4b09-bf8b-09e5b4ac3424	2026-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208898 application number: ANDA208898
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Preferred Pharmaceuticals Inc.	b94b5b36-c04e-45ee-b933-59c4302f2661	2026-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208898 application number: ANDA208898
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	REMEDYREPACK INC.	11fad602-16c2-4c1f-bdf1-867d95f063ca	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208898 application number: ANDA208898
ROSUVASTATIN	ROSUVASTATIN	DIRECT RX	99602058-4681-7cb5-e053-2995a90a099c	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208898 application number: ANDA208898
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	be73cea2-f89a-e4c5-e053-2a95a90a9cce	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208898 application number: ANDA208898
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Northwind Health Company, LLC	f2a1008e-963c-9999-e053-2a95a90ae726	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208898 application number: ANDA208898
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Northwind Health Company, LLC	e3d92523-2dbe-930b-e053-2a95a90ac3f2	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208898 application number: ANDA208898
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Quallent Pharmaceuticals Health LLC	6f978191-775e-4745-9c07-99e5be888afe	2025-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208898 application number: ANDA208898
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	dc7bfc79-9ee3-46e7-b55d-aba88648ad3b	2024-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208898 application number: ANDA208898
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Novadoz Pharmaceuticals LLC	d58f1f63-4bb6-413c-9730-ded3e8078618	2024-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208898 application number: ANDA208898 ndc (product): 72205-027
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	a9a5641f-9b7d-4a98-8dac-a3c53dde861f	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208898 application number: ANDA208898
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	199df185-dab0-4de1-95f7-a70e57b9c2b1	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208898 application number: ANDA208898
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	aaadbf01-9cf4-4898-9a96-f0a20d55702b	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208898 application number: ANDA208898
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	9e694f6a-63a0-55e9-e053-2995a90a10fe	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208898 application number: ANDA208898
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	a2155aff-bf13-3f00-e053-2995a90a4d1d	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208898 application number: ANDA208898
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	d6645266-9626-430e-bf04-b6426525ae0a	2024-05-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208898 application number: ANDA208898
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	3a03022c-ef11-4a68-829f-fae2d31969df	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208898 application number: ANDA208898
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	7ec15f53-a7ec-4be5-9f26-d1078117b18b	2023-12-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208898 application number: ANDA208898
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	8795a783-755d-426b-aa4f-1fc9965ba944	2023-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208898 application number: ANDA208898
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	adcbfc8c-e4a7-4576-9f0a-42c59c6e2ad1	2023-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208898 application number: ANDA208898

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
859424	rosuvastatin calcium 5 MG Oral Tablet	PSN	199df185-dab0-4de1-95f7-a70e57b9c2b1	102
859424	rosuvastatin calcium 5 MG Oral Tablet	SCD	199df185-dab0-4de1-95f7-a70e57b9c2b1	102
859747	rosuvastatin calcium 10 MG Oral Tablet	PSN	d58f1f63-4bb6-413c-9730-ded3e8078618	9
859751	rosuvastatin calcium 20 MG Oral Tablet	PSN	d58f1f63-4bb6-413c-9730-ded3e8078618	9
859419	rosuvastatin calcium 40 MG Oral Tablet	PSN	d58f1f63-4bb6-413c-9730-ded3e8078618	9
859424	rosuvastatin calcium 5 MG Oral Tablet	PSN	aaadbf01-9cf4-4898-9a96-f0a20d55702b	9
859424	rosuvastatin calcium 5 MG Oral Tablet	PSN	d58f1f63-4bb6-413c-9730-ded3e8078618	9
859747	rosuvastatin calcium 10 MG Oral Tablet	SCD	d58f1f63-4bb6-413c-9730-ded3e8078618	9
859751	rosuvastatin calcium 20 MG Oral Tablet	SCD	d58f1f63-4bb6-413c-9730-ded3e8078618	9
859419	rosuvastatin calcium 40 MG Oral Tablet	SCD	d58f1f63-4bb6-413c-9730-ded3e8078618	9
859424	rosuvastatin calcium 5 MG Oral Tablet	SCD	d58f1f63-4bb6-413c-9730-ded3e8078618	9
859424	rosuvastatin calcium 5 MG Oral Tablet	SCD	aaadbf01-9cf4-4898-9a96-f0a20d55702b	9
859419	rosuvastatin calcium 40 MG Oral Tablet	PSN	99602058-4681-7cb5-e053-2995a90a099c	7
859424	rosuvastatin calcium 5 MG Oral Tablet	PSN	99602058-4681-7cb5-e053-2995a90a099c	7
859419	rosuvastatin calcium 40 MG Oral Tablet	SCD	99602058-4681-7cb5-e053-2995a90a099c	7
859424	rosuvastatin calcium 5 MG Oral Tablet	SCD	99602058-4681-7cb5-e053-2995a90a099c	7
859424	rosuvastatin calcium 5 MG Oral Tablet	PSN	7ec15f53-a7ec-4be5-9f26-d1078117b18b	6
859424	rosuvastatin calcium 5 MG Oral Tablet	SCD	7ec15f53-a7ec-4be5-9f26-d1078117b18b	6
859424	rosuvastatin calcium 5 MG Oral Tablet	PSN	a2155aff-bf13-3f00-e053-2995a90a4d1d	3
859424	rosuvastatin calcium 5 MG Oral Tablet	PSN	31b3894a-1139-4f07-ac29-dda53844dc4b	3
859424	rosuvastatin calcium 5 MG Oral Tablet	SCD	a2155aff-bf13-3f00-e053-2995a90a4d1d	3
859424	rosuvastatin calcium 5 MG Oral Tablet	SCD	31b3894a-1139-4f07-ac29-dda53844dc4b	3
859424	rosuvastatin calcium 5 MG Oral Tablet	PSN	f77e97f3-aaed-0cd5-e053-6294a90aa395	2
859424	rosuvastatin calcium 5 MG Oral Tablet	SCD	f77e97f3-aaed-0cd5-e053-6294a90aa395	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72205-027-05	72205002705	500 TABLET, FILM COATED in 1 BOTTLE (72205-027-05)		2019-05-08	0000-00-00	No	No	Current
72205-027-06	72205002706	100 BLISTER PACK in 1 CARTON (72205-027-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK (72205-027-11)	100 blister pack	2019-05-08	0000-00-00	No	No	Current
72205-027-11	72205002711	10 in 1 BLISTER PACK						Historical
72205-027-90	72205002790	90 TABLET, FILM COATED in 1 BOTTLE (72205-027-90)		2019-05-08	0000-00-00	No	No	Current
72205-027-99	72205002799	1000 TABLET, FILM COATED in 1 BOTTLE (72205-027-99)		2019-05-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ROSUVASTATIN - DIRECT RX	DIRECT RX	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL	7
Rosuvastatin Calcium	Preferred Pharmaceuticals Inc.	2025-09-17	HUMAN PRESCRIPTION DRUG LABEL	3
Rosuvastatin Calcium	Novadoz Pharmaceuticals LLC \| MSN LABORATORIES PRIVATE LIMITED \| MSN Pharmaceuticals Inc.	2024-11-28	Human Prescription Drug Label	9
Rosuvastatin Calcium	REMEDYREPACK INC.	2024-09-18	HUMAN PRESCRIPTION DRUG LABEL	7
Rosuvastatin Calcium	Bryant Ranch Prepack	2024-08-29	HUMAN PRESCRIPTION DRUG LABEL	102
Rosuvastatin Calcium	A-S Medication Solutions	2024-08-20	Human Prescription Drug Label	9
Rosuvastatin Calcium	Northwind Pharmaceuticals, LLC	2024-06-28	HUMAN PRESCRIPTION DRUG LABEL	2
Rosuvastatin Calcium	NuCare Pharmaceuticals,Inc.	2024-06-20	HUMAN PRESCRIPTION DRUG LABEL	3
Rosuvastatin Calcium	A-S Medication Solutions	2023-12-28	Human Prescription Drug Label	6
Rosuvastatin Calcium	Preferred Pharmaceuticals, Inc.	2020-09-09	HUMAN PRESCRIPTION DRUG LABEL	2