ROSUVASTATIN CALCIUM

Product NDC: 68180-730
11-digit product format: 681800730
Labeler code: 68180
Product ID: 68180-730_abb25f86-915e-4e61-8221-cfebb4f71068
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ROSUVASTATIN CALCIUM
Dosage form: TABLET
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA205587
Marketing category: ANDA
Marketing start: 2017-07-31
Marketing end: 0000-00-00
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: 2019-12-31
Current FDA listing: Historical FDA.report record

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A205587-001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2017-07-31
A205587-002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2017-07-31
A205587-003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2017-07-31
A205587-004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2017-07-31

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 · 176 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
2026-10-15 13:18:30	2026-09	A205587-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2017-07-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205587-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2017-07-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205587-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2017-07-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205587-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2017-07-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A205587-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2017-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205587-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2017-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205587-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2017-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205587-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2017-07-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205587-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2017-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205587-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2017-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205587-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2017-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205587-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2017-07-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205587-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2017-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205587-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2017-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205587-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2017-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205587-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2017-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205587-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205587-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205587-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205587-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205587-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205587-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205587-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205587-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205587-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205587-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205587-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205587-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205587-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205587-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205587-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205587-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205587-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205587-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205587-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205587-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205587-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205587-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205587-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205587-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-07-31	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 156 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-03-12 10:30 UTC	2021-03	A205587-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205587-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205587-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205587-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205587-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205587-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205587-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205587-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205587-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205587-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205587-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205587-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205587-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205587-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205587-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205587-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205587-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205587-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205587-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205587-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205587-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205587-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205587-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205587-004	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205587-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205587-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205587-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205587-004	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205587-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A205587-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A205587-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A205587-004	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205587-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A205587-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A205587-003	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A205587-004	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205587-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205587-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205587-003	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205587-004	AB	1	`a72a2bbeb626…`

Reported adverse events (FAERS/openFDA)#

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

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	Strength	SPL version
68180-730-02	ROSUVASTATIN CALCIUM	500 in 1 BOTTLE	TABLET	500		7
68180-730-09	ROSUVASTATIN CALCIUM	90 in 1 BOTTLE	TABLET	90		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-730	ROSUVASTATIN CALCIUM TABLET [LUPIN PHARMACEUTICALS, INC.]	7	Legacy NDC, 2 package rows	20181026_f68aa10b-d6bd-4fb4-a652-fad85efdaabd.zip

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	f68aa10b-d6bd-4fb4-a652-fad85efdaabd	7
859751	rosuvastatin calcium 20 MG Oral Tablet	PSN	f68aa10b-d6bd-4fb4-a652-fad85efdaabd	7
859419	rosuvastatin calcium 40 MG Oral Tablet	PSN	f68aa10b-d6bd-4fb4-a652-fad85efdaabd	7
859424	rosuvastatin calcium 5 MG Oral Tablet	PSN	f68aa10b-d6bd-4fb4-a652-fad85efdaabd	7
859747	rosuvastatin calcium 10 MG Oral Tablet	SCD	f68aa10b-d6bd-4fb4-a652-fad85efdaabd	7
859751	rosuvastatin calcium 20 MG Oral Tablet	SCD	f68aa10b-d6bd-4fb4-a652-fad85efdaabd	7
859419	rosuvastatin calcium 40 MG Oral Tablet	SCD	f68aa10b-d6bd-4fb4-a652-fad85efdaabd	7
859424	rosuvastatin calcium 5 MG Oral Tablet	SCD	f68aa10b-d6bd-4fb4-a652-fad85efdaabd	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68180-730-02	68180073002	500 in 1 BOTTLE	Historical
68180-730-09	68180073009	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ROSUVASTATIN CALCIUM	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2018-10-26	HUMAN PRESCRIPTION DRUG LABEL	7