ROSZET

Product NDC: 70661-003
11-digit product format: 706610003
Labeler code: 70661
Product ID: 70661-003_a3a6aab1-44b6-4670-bbdc-516f33274d99
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: (rosuvastatin and ezetimibe)
Dosage form: TABLET
Route: ORAL
Labeler: Althera Pharmaceuticals LLC
Application: NDA213072
Marketing category: NDA
Marketing start: 2021-05-10
Marketing end: 0000-00-00
Substance: ROSUVASTATIN CALCIUM; EZETIMIBE
Active strength: 21 mg/1; mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA],Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	70661-003		D	Discontinued by firm	2026-08-11
excluded package	package	70661-003	70661-003-10	D	Discontinued by firm	2026-08-11
excluded package	package	70661-003	70661-003-30	D	Discontinued by firm	2026-08-11
excluded package	package	70661-003	70661-003-39	D	Discontinued by firm	2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70661-003-39	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70661-003-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70661-003-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70661-003-39	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70661-003-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70661-003-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70661-003-39	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70661-003-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70661-003-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70661-003-39	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70661-003-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70661-003-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70661-003-39	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70661-003-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70661-003-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70661-003-39	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70661-003-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70661-003-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70661-003-39	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70661-003-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70661-003-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70661-003-39	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70661-003-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70661-003-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70661-003-39	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70661-003-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70661-003-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70661-003-39	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70661-003-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70661-003-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70661-003-39	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70661-003-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70661-003-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70661-003-39	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70661-003-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70661-003-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	RLD / RS	Approval date
N213072-001	ROSZET	EZETIMIBE; ROSUVASTATIN CALCIUM	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2021-03-23
N213072-002	ROSZET	EZETIMIBE; ROSUVASTATIN CALCIUM	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-03-23
N213072-003	ROSZET	EZETIMIBE; ROSUVASTATIN CALCIUM	10MG;EQ 20MG BASE	TABLET / ORAL	RLD	2021-03-23
N213072-004	ROSZET	EZETIMIBE; ROSUVASTATIN CALCIUM	10MG;EQ 40MG BASE	TABLET / ORAL	RLD	2021-03-23

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213072-001	10376470	2033-05-01	U-3095	Drug product	2021-03-29
N213072-001	9763885	2033-05-01	U-3095	Drug product	2021-03-29
N213072-002	10376470	2033-05-01	U-3095	Drug product	2021-03-29
N213072-002	9763885	2033-05-01	U-3095	Drug product	2021-03-29
N213072-003	10376470	2033-05-01	U-3095	Drug product	2021-03-29
N213072-003	9763885	2033-05-01	U-3095	Drug product	2021-03-29
N213072-004	10376470	2033-05-01	U-3095	Drug product	2021-03-29
N213072-004	9763885	2033-05-01	U-3095	Drug product	2021-03-29

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 4 · 136 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213072-001	ROSZET	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2021-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213072-002	ROSZET	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213072-003	ROSZET	10MG;EQ 20MG BASE	TABLET / ORAL	RLD	2021-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213072-004	ROSZET	10MG;EQ 40MG BASE	TABLET / ORAL	RLD	2021-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213072-001	ROSZET	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2021-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213072-002	ROSZET	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213072-003	ROSZET	10MG;EQ 20MG BASE	TABLET / ORAL	RLD	2021-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213072-004	ROSZET	10MG;EQ 40MG BASE	TABLET / ORAL	RLD	2021-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213072-001	ROSZET	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2021-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213072-002	ROSZET	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213072-003	ROSZET	10MG;EQ 20MG BASE	TABLET / ORAL	RLD	2021-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213072-004	ROSZET	10MG;EQ 40MG BASE	TABLET / ORAL	RLD	2021-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213072-001	ROSZET	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2021-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213072-002	ROSZET	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213072-003	ROSZET	10MG;EQ 20MG BASE	TABLET / ORAL	RLD	2021-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213072-004	ROSZET	10MG;EQ 40MG BASE	TABLET / ORAL	RLD	2021-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213072-001	ROSZET	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2021-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213072-002	ROSZET	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213072-003	ROSZET	10MG;EQ 20MG BASE	TABLET / ORAL	RLD	2021-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213072-004	ROSZET	10MG;EQ 40MG BASE	TABLET / ORAL	RLD	2021-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213072-001	ROSZET	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2021-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213072-002	ROSZET	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213072-003	ROSZET	10MG;EQ 20MG BASE	TABLET / ORAL	RLD	2021-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213072-004	ROSZET	10MG;EQ 40MG BASE	TABLET / ORAL	RLD	2021-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213072-001	ROSZET	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2021-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213072-002	ROSZET	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213072-003	ROSZET	10MG;EQ 20MG BASE	TABLET / ORAL	RLD	2021-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213072-004	ROSZET	10MG;EQ 40MG BASE	TABLET / ORAL	RLD	2021-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213072-001	ROSZET	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2021-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213072-002	ROSZET	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213072-003	ROSZET	10MG;EQ 20MG BASE	TABLET / ORAL	RLD	2021-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213072-004	ROSZET	10MG;EQ 40MG BASE	TABLET / ORAL	RLD	2021-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213072-001	ROSZET	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2021-03-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213072-002	ROSZET	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-03-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213072-003	ROSZET	10MG;EQ 20MG BASE	TABLET / ORAL	RLD	2021-03-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213072-004	ROSZET	10MG;EQ 40MG BASE	TABLET / ORAL	RLD	2021-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213072-001	ROSZET	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2021-03-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213072-002	ROSZET	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-03-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213072-003	ROSZET	10MG;EQ 20MG BASE	TABLET / ORAL	RLD	2021-03-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213072-004	ROSZET	10MG;EQ 40MG BASE	TABLET / ORAL	RLD	2021-03-23	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 272 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213072-001	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213072-001	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213072-002	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213072-002	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213072-003	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213072-003	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213072-004	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213072-004	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213072-001	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213072-001	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213072-002	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213072-002	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213072-003	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213072-003	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213072-004	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213072-004	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213072-001	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213072-001	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213072-002	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213072-002	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213072-003	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213072-003	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213072-004	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213072-004	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213072-001	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213072-001	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213072-002	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213072-002	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213072-003	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213072-003	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213072-004	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213072-004	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213072-001	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213072-001	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213072-002	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213072-002	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213072-003	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213072-003	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213072-004	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213072-004	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`b8a1b40f171c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70661-003-30	EA - Each	70661-003	31b54340-35c4-43ec-8592-6b41841713f0	1	2021-05-05

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
83MVU38M7Q	ROSUVASTATIN CALCIUM	147098-20-2	ROSUVASTATIN CALCIUM
EOR26LQQ24	EZETIMIBE	163222-33-1	EZETIMIBE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70661-003-10	70661000310	10 TABLET in 1 BOTTLE (70661-003-10)	10 tablet	2021-06-15	0000-00-00	Yes	No	Current
70661-003-30	70661000330	30 TABLET in 1 BOTTLE (70661-003-30)	30 tablet	2021-05-10	0000-00-00	No	No	Current
70661-003-39	70661000339	30 TABLET in 1 BOTTLE (70661-003-39)	30 tablet	2021-05-10	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ROSZET	Althera Pharmaceuticals LLC \| Piramal Pharma Limited	2021-09-15	HUMAN PRESCRIPTION DRUG LABEL	7