Rosuvastatin Calcium

Product NDC: 47335-583
11-digit product format: 473350583
Labeler code: 47335
Product ID: 47335-583_c84142c8-6ffe-433c-830c-e6bdd1729605
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
Marketing end: 0000-00-00
Substance: ROSUVASTATIN CALCIUM
Active strength: 10 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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	47335-583		D	Discontinued by firm	2026-10-15
excluded package	package	47335-583	47335-583-18	D	Discontinued by firm	2026-10-15
excluded package	package	47335-583	47335-583-81	D	Discontinued by firm	2026-10-15
excluded package	package	47335-583	47335-583-83	D	Discontinued by firm	2026-10-15

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
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 · 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	A079169-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2016-07-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A079169-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2016-07-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A079169-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2016-07-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A079169-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2016-07-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A079169-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2016-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079169-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2016-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079169-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2016-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079169-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2016-07-19	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 130 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A079169-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079169-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079169-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079169-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079169-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079169-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079169-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079169-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079169-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079169-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079169-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079169-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079169-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079169-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079169-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A079169-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A079169-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A079169-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079169-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079169-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079169-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079169-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079169-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A079169-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A079169-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A079169-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079169-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079169-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079169-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079169-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079169-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079169-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079169-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079169-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079169-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079169-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079169-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079169-004	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079169-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079169-002	AB	1	`6a51e52b5d6a…`

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	SPL version
47335-583-18	Rosuvastatin Calcium	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	16
47335-583-81	Rosuvastatin Calcium	90 in 1 BOTTLE	TABLET, FILM COATED	90	16
47335-583-83	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
47335-583	ROSUVASTATIN CALCIUM TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	16	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
47335-583-18	47335058318	1000 in 1 BOTTLE					Historical
47335-583-81	47335058381	90 TABLET, FILM COATED in 1 BOTTLE (47335-583-81)	2021-03-01	0000-00-00	No	No	Current
47335-583-83	47335058383	30 in 1 BOTTLE					Historical

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