Rosuvastatin Calcium

Product NDC: 47335-585
11-digit product format: 473350585
Labeler code: 47335
Product ID: 47335-585_1fa645cf-c870-4b0b-b6b3-53c2f1c32a6f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rosuvastatin Calcium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA079169
Marketing category: ANDA
Marketing start: 2021-03-01
Substance: ROSUVASTATIN CALCIUM
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	47335-585		D	Discontinued by firm	2026-08-17
excluded package	package	47335-585	47335-585-18	D	Discontinued by firm	2026-08-17
excluded package	package	47335-585	47335-585-81	D	Discontinued by firm	2026-08-17
excluded package	package	47335-585	47335-585-83	D	Discontinued by firm	2026-08-17

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	Approval date
A079169-001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2016-07-19
A079169-002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2016-07-19
A079169-003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2016-07-19
A079169-004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2016-07-19

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	A079169-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2016-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079169-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2016-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079169-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2016-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079169-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2016-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079169-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079169-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079169-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079169-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2016-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079169-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2016-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079169-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2016-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079169-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2016-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079169-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2016-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079169-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2016-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079169-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2016-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079169-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2016-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079169-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2016-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079169-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2016-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079169-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2016-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079169-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2016-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079169-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2016-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079169-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2016-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079169-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2016-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079169-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2016-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079169-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2016-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079169-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2016-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079169-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2016-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079169-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2016-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079169-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2016-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079169-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2016-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079169-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2016-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079169-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2016-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079169-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079169-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079169-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079169-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079169-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079169-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2016-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079169-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2016-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079169-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2016-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079169-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 130 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079169-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079169-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079169-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079169-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079169-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079169-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079169-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079169-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079169-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079169-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079169-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079169-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079169-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079169-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079169-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079169-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079169-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079169-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079169-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079169-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079169-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079169-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079169-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079169-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079169-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079169-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079169-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079169-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079169-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079169-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079169-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079169-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079169-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079169-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079169-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079169-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079169-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079169-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079169-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079169-002	AB	1	`74a2ff9319b5…`

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
47335-585-18	Rosuvastatin Calcium	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	16
47335-585-81	Rosuvastatin Calcium	90 in 1 BOTTLE	TABLET, FILM COATED	90	16
47335-585-83	Rosuvastatin Calcium	30 in 1 BOTTLE	TABLET, FILM COATED	30	16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-585	ROSUVASTATIN CALCIUM TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	16	Current NDC, Legacy NDC, 3 package rows	20240831_ef243da2-d388-40e4-a1cb-a5e0688efc49.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
83MVU38M7Q	ROSUVASTATIN CALCIUM	147098-20-2	ROSUVASTATIN CALCIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-585-18	47335058518	1000 TABLET, FILM COATED in 1 BOTTLE (47335-585-18)	2023-06-23		No	No	Historical
47335-585-81	47335058581	90 TABLET, FILM COATED in 1 BOTTLE (47335-585-81)	2023-06-23		No	No	Historical
47335-585-83	47335058583	30 TABLET, FILM COATED in 1 BOTTLE (47335-585-83)	2021-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rosuvastatin Calcium	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2024-08-08	Human Prescription Drug Label	16