LYPQOZET

Product NDC: 70661-008
Requested package NDC: 70661-008-90
11-digit product format: 706610008
Labeler code: 70661
Product ID: 70661-008_bd0e8df1-2810-4543-8600-ad6c45c399d6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: (ezetimibe and atorvastatin)
Dosage form: TABLET
Route: ORAL
Labeler: Althera Pharmaceuticals, LLC
Application: ANDA206084
Marketing category: ANDA
Marketing start: 2021-01-14
Marketing end: 0000-00-00
Substance: ATORVASTATIN CALCIUM TRIHYDRATE; EZETIMIBE
Active strength: 83 mg/1; mg/1
Pharmacologic classes: Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70661-008	70661-008-90	I	Inactivated by FDA		2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70661-008	70661-008-90	I	Inactivated by FDA		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70661-008	70661-008-90	I	Inactivated by FDA		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A206084-001	LYPQOZET	ATORVASTATIN CALCIUM; EZETIMIBE	EQ 10MG BASE;10MG	TABLET / ORAL	2017-04-26
A206084-002	LYPQOZET	ATORVASTATIN CALCIUM; EZETIMIBE	EQ 20MG BASE;10MG	TABLET / ORAL	2017-04-26
A206084-003	LYPQOZET	ATORVASTATIN CALCIUM; EZETIMIBE	EQ 40MG BASE;10MG	TABLET / ORAL	2017-04-26
A206084-004	LYPQOZET	ATORVASTATIN CALCIUM; EZETIMIBE	EQ 80MG BASE;10MG	TABLET / ORAL	2017-04-26

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A206084-001	LYPQOZET	EQ 10MG BASE;10MG	TABLET / ORAL		2017-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206084-002	LYPQOZET	EQ 20MG BASE;10MG	TABLET / ORAL		2017-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206084-003	LYPQOZET	EQ 40MG BASE;10MG	TABLET / ORAL		2017-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206084-004	LYPQOZET	EQ 80MG BASE;10MG	TABLET / ORAL		2017-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206084-001	LYPQOZET	EQ 10MG BASE;10MG	TABLET / ORAL		2017-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206084-002	LYPQOZET	EQ 20MG BASE;10MG	TABLET / ORAL		2017-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206084-003	LYPQOZET	EQ 40MG BASE;10MG	TABLET / ORAL		2017-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206084-004	LYPQOZET	EQ 80MG BASE;10MG	TABLET / ORAL	RS	2017-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206084-001	LYPQOZET	EQ 10MG BASE;10MG	TABLET / ORAL		2017-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206084-002	LYPQOZET	EQ 20MG BASE;10MG	TABLET / ORAL		2017-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206084-003	LYPQOZET	EQ 40MG BASE;10MG	TABLET / ORAL		2017-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206084-004	LYPQOZET	EQ 80MG BASE;10MG	TABLET / ORAL	RS	2017-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206084-001	LYPQOZET	EQ 10MG BASE;10MG	TABLET / ORAL		2017-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206084-002	LYPQOZET	EQ 20MG BASE;10MG	TABLET / ORAL		2017-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206084-003	LYPQOZET	EQ 40MG BASE;10MG	TABLET / ORAL		2017-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206084-004	LYPQOZET	EQ 80MG BASE;10MG	TABLET / ORAL	RS	2017-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206084-001	LYPQOZET	EQ 10MG BASE;10MG	TABLET / ORAL		2017-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206084-002	LYPQOZET	EQ 20MG BASE;10MG	TABLET / ORAL		2017-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206084-003	LYPQOZET	EQ 40MG BASE;10MG	TABLET / ORAL		2017-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206084-004	LYPQOZET	EQ 80MG BASE;10MG	TABLET / ORAL	RS	2017-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206084-001	LYPQOZET	EQ 10MG BASE;10MG	TABLET / ORAL		2017-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206084-002	LYPQOZET	EQ 20MG BASE;10MG	TABLET / ORAL		2017-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206084-003	LYPQOZET	EQ 40MG BASE;10MG	TABLET / ORAL		2017-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206084-004	LYPQOZET	EQ 80MG BASE;10MG	TABLET / ORAL	RS	2017-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206084-001	LYPQOZET	EQ 10MG BASE;10MG	TABLET / ORAL		2017-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206084-002	LYPQOZET	EQ 20MG BASE;10MG	TABLET / ORAL		2017-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206084-003	LYPQOZET	EQ 40MG BASE;10MG	TABLET / ORAL		2017-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206084-004	LYPQOZET	EQ 80MG BASE;10MG	TABLET / ORAL	RS	2017-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206084-001	LYPQOZET	EQ 10MG BASE;10MG	TABLET / ORAL		2017-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206084-002	LYPQOZET	EQ 20MG BASE;10MG	TABLET / ORAL		2017-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206084-003	LYPQOZET	EQ 40MG BASE;10MG	TABLET / ORAL		2017-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206084-004	LYPQOZET	EQ 80MG BASE;10MG	TABLET / ORAL	RS	2017-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206084-001	LYPQOZET	EQ 10MG BASE;10MG	TABLET / ORAL		2017-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206084-002	LYPQOZET	EQ 20MG BASE;10MG	TABLET / ORAL		2017-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206084-003	LYPQOZET	EQ 40MG BASE;10MG	TABLET / ORAL		2017-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206084-004	LYPQOZET	EQ 80MG BASE;10MG	TABLET / ORAL	RS	2017-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206084-001	LYPQOZET	EQ 10MG BASE;10MG	TABLET / ORAL		2017-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206084-002	LYPQOZET	EQ 20MG BASE;10MG	TABLET / ORAL		2017-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206084-003	LYPQOZET	EQ 40MG BASE;10MG	TABLET / ORAL		2017-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206084-004	LYPQOZET	EQ 80MG BASE;10MG	TABLET / ORAL	RS	2017-04-26	`d8e5a09893c0…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fa898d56-9495-d6f0-309b-68a5d8e3914a	Product name	4	20260305
d25cba4b-d79e-4890-8837-1382f7d09489	Product name	1	20231002
91774e91-b249-45e3-8ff8-4b5db2927a69	Product name	1	20230718
93a156a6-903b-1690-4dc3-a57adfaa8c1a	Product name	9	20230322
03fb3cda-d60a-4873-94e9-6fa77cfb1a1c	Product name	1	20220302
c8f25656-847a-4de8-96a7-06bf98d83c2b	Product name	1	20210916
34152997-af0b-acf4-dcaf-37211afe8ca4	Product name	9	20210312
b249faa8-b784-47ef-8ad4-031ef248fa73	Product name	1	20200626
c4422d73-8e69-1539-606a-32a25fa00ebc	Product name	4	20190926
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70661-008-30	2025-07-29	These highlights do not include all the information needed to use LYPQOZET safely and effectively. See full prescribing information for LYPQOZET LYPQOZET ® (ezetimibe and atorvastatin) tablets for oral use Initial U.S. Approval: 2013
70661-008-90	2025-07-29	These highlights do not include all the information needed to use LYPQOZET safely and effectively. See full prescribing information for LYPQOZET LYPQOZET ® (ezetimibe and atorvastatin) tablets for oral use Initial U.S. Approval: 2013
70661-008-30	2024-01-31	These highlights do not include all the information needed to use LYPQOZET safely and effectively. See full prescribing information for LYPQOZET LYPQOZET ® (ezetimibe and atorvastatin) tablets for oral use Initial U.S. Approval: 2013
70661-008-90	2024-01-31	These highlights do not include all the information needed to use LYPQOZET safely and effectively. See full prescribing information for LYPQOZET LYPQOZET ® (ezetimibe and atorvastatin) tablets for oral use Initial U.S. Approval: 2013

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70661-008-30	LYPQOZET	30 in 1 BOTTLE	TABLET	30		2
70661-008-90	LYPQOZET	90 in 1 BOTTLE	TABLET	90		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70661-008	LYPQOZET ((EZETIMIBE AND ATORVASTATIN)) TABLET [ALTHERA PHARMACEUTICALS, LLC]	2	Legacy NDC, 2 package rows	20240201_6375eae7-e159-4fb2-a91c-9aa20ac3c9e1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
48A5M73Z4Q	ATORVASTATIN CALCIUM TRIHYDRATE	344423-98-9	ATORVASTATIN CALCIUM TRIHYDRATE
EOR26LQQ24	EZETIMIBE	163222-33-1	EZETIMIBE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1422086	ezetimibe 10 MG / atorvastatin 10 MG Oral Tablet	PSN	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
1422093	ezetimibe 10 MG / atorvastatin 20 MG Oral Tablet	PSN	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
1422096	ezetimibe 10 MG / atorvastatin 40 MG Oral Tablet	PSN	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
1422099	ezetimibe 10 MG / atorvastatin 80 MG Oral Tablet	PSN	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
2611248	LYPQOZET 10 MG / 10 MG Oral Tablet	PSN	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
2611250	LYPQOZET 10 MG / 20 MG Oral Tablet	PSN	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
2611252	LYPQOZET 10 MG / 40 MG Oral Tablet	PSN	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
2611254	LYPQOZET 10 MG / 80 MG Oral Tablet	PSN	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
2611248	atorvastatin 10 MG / ezetimibe 10 MG Oral Tablet [Lypqozet]	SBD	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
2611250	atorvastatin 20 MG / ezetimibe 10 MG Oral Tablet [Lypqozet]	SBD	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
2611252	atorvastatin 40 MG / ezetimibe 10 MG Oral Tablet [Lypqozet]	SBD	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
2611254	atorvastatin 80 MG / ezetimibe 10 MG Oral Tablet [Lypqozet]	SBD	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
1422086	atorvastatin 10 MG / ezetimibe 10 MG Oral Tablet	SCD	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
1422093	atorvastatin 20 MG / ezetimibe 10 MG Oral Tablet	SCD	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
1422096	atorvastatin 40 MG / ezetimibe 10 MG Oral Tablet	SCD	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
1422099	atorvastatin 80 MG / ezetimibe 10 MG Oral Tablet	SCD	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
1422086	atorvastatin 10 MG (as atorvastatin calcium 10.34 MG) / ezetimibe 10 MG Oral Tablet	SY	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
1422093	atorvastatin 20 MG (as atorvastatin calcium 20.68 MG) / ezetimibe 10 MG Oral Tablet	SY	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
1422096	atorvastatin 40 MG (as atorvastatin calcium 41.37 MG) / ezetimibe 10 MG Oral Tablet	SY	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
1422099	atorvastatin 80 MG (as atorvastatin calcium 82.73 MG) / ezetimibe 10 MG Oral Tablet	SY	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
2611248	Lypqozet (atorvastatin 10 MG (as atorvastatin calcium 10.34 MG) / ezetimibe 10 MG) Oral Tablet	SY	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
2611250	Lypqozet (atorvastatin 20 MG (as atorvastatin calcium 20.68 MG) / ezetimibe 10 MG) Oral Tablet	SY	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
2611252	Lypqozet (atorvastatin 40 MG (as atorvastatin calcium 41.37 MG) / ezetimibe 10 MG) Oral Tablet	SY	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2
2611254	Lypqozet (atorvastatin 80 MG (as atorvastatin calcium 82.73 MG) / ezetimibe 10 MG) Oral Tablet	SY	6375eae7-e159-4fb2-a91c-9aa20ac3c9e1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70661-008-90	70661000890	90 TABLET in 1 BOTTLE (70661-008-90)	90 tablet	2021-01-14	0000-00-00	No	No	Current