rosuvstatin

Product NDC: 70756-053
11-digit product format: 707560053
Labeler code: 70756
Product ID: 70756-053_712bec41-1dc6-4d6d-9882-48ff6d734f31
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rosuvstatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Lifestar Pharma LLC
Application: ANDA206603
Marketing category: ANDA
Marketing start: 2026-08-16
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: 2027-12-31
Current FDA listing: Yes

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
A206603-001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2025-05-16
A206603-002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2025-05-16
A206603-003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2025-05-16
A206603-004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2025-05-16

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.

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	A206603-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2025-05-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206603-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2025-05-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206603-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2025-05-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206603-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2025-05-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A206603-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2025-05-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206603-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2025-05-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206603-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2025-05-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206603-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2025-05-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206603-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2025-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206603-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2025-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206603-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2025-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206603-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2025-05-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206603-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2025-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206603-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2025-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206603-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2025-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206603-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2025-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206603-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2025-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206603-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2025-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206603-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2025-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206603-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2025-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206603-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2025-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206603-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2025-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206603-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2025-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206603-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2025-05-16	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206603-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL		2025-05-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206603-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL		2025-05-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206603-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL		2025-05-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206603-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL		2025-05-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A206603-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206603-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206603-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206603-004	AB	1	`6a471c1ec25d…`

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: rosuvstatin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ROSUVASTATIN CALCIUM	5 mg/1

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
70756-053-12	rosuvstatin	1000 in 1 BOTTLE	TABLET, FILM COATED	1000		7
70756-053-90	rosuvstatin	90 in 1 BOTTLE	TABLET, FILM COATED	90		7

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	a6141eb6-0b38-44f9-9d16-ec7218a51f92	7
859751	rosuvastatin calcium 20 MG Oral Tablet	PSN	a6141eb6-0b38-44f9-9d16-ec7218a51f92	7
859419	rosuvastatin calcium 40 MG Oral Tablet	PSN	a6141eb6-0b38-44f9-9d16-ec7218a51f92	7
859424	rosuvastatin calcium 5 MG Oral Tablet	PSN	a6141eb6-0b38-44f9-9d16-ec7218a51f92	7
859747	rosuvastatin calcium 10 MG Oral Tablet	SCD	a6141eb6-0b38-44f9-9d16-ec7218a51f92	7
859751	rosuvastatin calcium 20 MG Oral Tablet	SCD	a6141eb6-0b38-44f9-9d16-ec7218a51f92	7
859419	rosuvastatin calcium 40 MG Oral Tablet	SCD	a6141eb6-0b38-44f9-9d16-ec7218a51f92	7
859424	rosuvastatin calcium 5 MG Oral Tablet	SCD	a6141eb6-0b38-44f9-9d16-ec7218a51f92	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70756-053-12	70756005312	1000 TABLET, FILM COATED in 1 BOTTLE (70756-053-12)	2026-08-16	No	No	Current
70756-053-90	70756005390	90 TABLET, FILM COATED in 1 BOTTLE (70756-053-90)	2026-08-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
rosuvstatin	Lifestar Pharma LLC \| Mankind Pharma Limited	2026-10-08	HUMAN PRESCRIPTION DRUG LABEL	10