Rosuvastatin calcium

Product NDC: 70377-006
Requested package NDC: 70377-006-13
11-digit product format: 703770006
Labeler code: 70377
Product ID: 70377-006_843cb1f2-e29f-1cea-4a98-e34470827fba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rosuvastatin calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Biocon Pharma Inc
Application: ANDA207752
Marketing category: ANDA
Marketing start: 2016-10-31
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 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
A207752-001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31
A207752-002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31
A207752-003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31
A207752-004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207752-001	AB
A207752-002	AB
A207752-003	AB
A207752-004	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	A207752-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207752-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207752-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207752-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207752-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207752-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207752-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207752-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207752-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207752-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207752-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207752-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207752-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207752-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207752-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207752-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207752-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207752-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207752-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207752-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207752-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207752-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207752-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207752-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207752-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207752-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207752-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207752-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207752-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207752-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207752-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207752-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207752-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207752-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207752-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207752-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207752-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207752-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207752-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207752-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A207752-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207752-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207752-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207752-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207752-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207752-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207752-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207752-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207752-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207752-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207752-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207752-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207752-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207752-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207752-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207752-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207752-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207752-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207752-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207752-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207752-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207752-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207752-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207752-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207752-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207752-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207752-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207752-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207752-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207752-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207752-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207752-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207752-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207752-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207752-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207752-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207752-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207752-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207752-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207752-004	AB	1	`d06236e962d9…`

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
033d8c8f-bbe9-96b5-fd53-cb0ef929857a	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70377-006-11	2022-02-10	These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS . ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
70377-006-12	2022-02-10	These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS . ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
70377-006-13	2022-02-10	These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS . ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
70377-006-15	2022-02-10	These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS . ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
70377-006-11	2022-01-28	These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS . ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
70377-006-12	2022-01-28	These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS . ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
70377-006-13	2022-01-28	These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS . ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
70377-006-15	2022-01-28	These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS . ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70377-006-11	Rosuvastatin calcium	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	19
70377-006-12	Rosuvastatin calcium	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	19
70377-006-13	Rosuvastatin calcium	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	19
70377-006-15	Rosuvastatin calcium	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1000	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70377-006-12	EA - Each	70377-006	fdb6f86f-dae8-4bd7-b720-3e15c5321c53	1	2017-05-04
70377-006-13	EA - Each	70377-006	19cb0d27-9eae-4453-a00c-57e3cd17a5bb	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70377-006	ROSUVASTATIN CALCIUM TABLET, FILM COATED [BIOCON PHARMA INC]	16	Current NDC, Legacy NDC, 4 package rows	20240622_033d8c8f-bbe9-96b5-fd53-cb0ef929857a.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Biocon Pharma Inc	033d8c8f-bbe9-96b5-fd53-cb0ef929857a	2025-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207752 application number: ANDA207752 ndc (package): 70377-006-13 ndc (product): 70377-006 ndc11 (package): 70377000613
ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	9333c674-5714-41ed-8a16-dc7c3e50b9a4	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207752 application number: ANDA207752
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	51d0ef20-c80d-44de-ac85-9b73608dba0b	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207752 application number: ANDA207752
ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	128d52ea-abad-c8ef-e063-6394a90a3fec	2024-02-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207752 application number: ANDA207752
ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	113160c7-7b41-5395-e063-6394a90a1e15	2024-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207752 application number: ANDA207752
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	eeb492b0-32d8-489e-ab60-6eec52a28efd	2023-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207752 application number: ANDA207752
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	e41da8b8-db23-49e1-9ee0-55423d285980	2023-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207752 application number: ANDA207752
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	88ab1c85-e864-4879-8489-8365ded78bb5	2023-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207752 application number: ANDA207752
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	9b8f614f-d49c-464b-b580-5fb9f2c25681	2023-09-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207752 application number: ANDA207752
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	5f392edb-f7fc-40b4-8446-35494e83a69e	2023-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207752 application number: ANDA207752
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	d1bd91fd-03fa-4e6c-80c1-ce58b158d8d6	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207752 application number: ANDA207752
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	cbef0681-705c-48fd-add9-1042658ef85d	2018-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207752 application number: ANDA207752

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	e41da8b8-db23-49e1-9ee0-55423d285980	102
859424	rosuvastatin calcium 5 MG Oral Tablet	SCD	e41da8b8-db23-49e1-9ee0-55423d285980	102
859747	rosuvastatin calcium 10 MG Oral Tablet	PSN	033d8c8f-bbe9-96b5-fd53-cb0ef929857a	19
859751	rosuvastatin calcium 20 MG Oral Tablet	PSN	033d8c8f-bbe9-96b5-fd53-cb0ef929857a	19
859419	rosuvastatin calcium 40 MG Oral Tablet	PSN	033d8c8f-bbe9-96b5-fd53-cb0ef929857a	19
859424	rosuvastatin calcium 5 MG Oral Tablet	PSN	033d8c8f-bbe9-96b5-fd53-cb0ef929857a	19
859747	rosuvastatin calcium 10 MG Oral Tablet	SCD	033d8c8f-bbe9-96b5-fd53-cb0ef929857a	19
859751	rosuvastatin calcium 20 MG Oral Tablet	SCD	033d8c8f-bbe9-96b5-fd53-cb0ef929857a	19
859419	rosuvastatin calcium 40 MG Oral Tablet	SCD	033d8c8f-bbe9-96b5-fd53-cb0ef929857a	19
859424	rosuvastatin calcium 5 MG Oral Tablet	SCD	033d8c8f-bbe9-96b5-fd53-cb0ef929857a	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70377-006-13	70377000613	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-006-13)	2016-10-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rosuvastatin calcium	Biocon Pharma Inc \| Biocon Limited \| Recipharm Pharmaservices Private Limited \| Biocon Pharma Limited	2025-05-30	HUMAN PRESCRIPTION DRUG LABEL	19
Rosuvastatin calcium	Bryant Ranch Prepack	2023-11-20	HUMAN PRESCRIPTION DRUG LABEL	102