FDA.reportPublic FDA data

LYPQOZET

Product NDC
70661-006
11-digit product format
706610006
Labeler code
70661
Product ID
70661-006_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
21 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
93a156a6-903b-1690-4dc3-a57adfaa8c1aProduct name920230322
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
b249faa8-b784-47ef-8ad4-031ef248fa73Product name120200626
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70661-006-302025-07-29C16284748780-11030e365-1a61-111a-e063-dadaa90a10e2These 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
70661-006-902025-07-29C16284748780-11030e365-1a61-111a-e063-dadaa90a10e2These 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
70661-006-302024-01-31C16284748780-11030e365-1a61-111a-e063-dadaa90a10e2These 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
70661-006-902024-01-31C16284748780-11030e365-1a61-111a-e063-dadaa90a10e2These 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 NDCProductDescriptionFormQuantityStrengthSPL version
70661-006-30LYPQOZET30 in 1 BOTTLETABLET302
70661-006-90LYPQOZET90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70661-006LYPQOZET ((EZETIMIBE AND ATORVASTATIN)) TABLET [ALTHERA PHARMACEUTICALS, LLC]2Legacy NDC, 2 package rows20240201_6375eae7-e159-4fb2-a91c-9aa20ac3c9e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1422086ezetimibe 10 MG / atorvastatin 10 MG Oral TabletPSN6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
1422093ezetimibe 10 MG / atorvastatin 20 MG Oral TabletPSN6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
1422096ezetimibe 10 MG / atorvastatin 40 MG Oral TabletPSN6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
1422099ezetimibe 10 MG / atorvastatin 80 MG Oral TabletPSN6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
2611248LYPQOZET 10 MG / 10 MG Oral TabletPSN6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
2611250LYPQOZET 10 MG / 20 MG Oral TabletPSN6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
2611252LYPQOZET 10 MG / 40 MG Oral TabletPSN6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
2611254LYPQOZET 10 MG / 80 MG Oral TabletPSN6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
2611248atorvastatin 10 MG / ezetimibe 10 MG Oral Tablet [Lypqozet]SBD6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
2611250atorvastatin 20 MG / ezetimibe 10 MG Oral Tablet [Lypqozet]SBD6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
2611252atorvastatin 40 MG / ezetimibe 10 MG Oral Tablet [Lypqozet]SBD6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
2611254atorvastatin 80 MG / ezetimibe 10 MG Oral Tablet [Lypqozet]SBD6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
1422086atorvastatin 10 MG / ezetimibe 10 MG Oral TabletSCD6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
1422093atorvastatin 20 MG / ezetimibe 10 MG Oral TabletSCD6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
1422096atorvastatin 40 MG / ezetimibe 10 MG Oral TabletSCD6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
1422099atorvastatin 80 MG / ezetimibe 10 MG Oral TabletSCD6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
1422086atorvastatin 10 MG (as atorvastatin calcium 10.34 MG) / ezetimibe 10 MG Oral TabletSY6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
1422093atorvastatin 20 MG (as atorvastatin calcium 20.68 MG) / ezetimibe 10 MG Oral TabletSY6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
1422096atorvastatin 40 MG (as atorvastatin calcium 41.37 MG) / ezetimibe 10 MG Oral TabletSY6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
1422099atorvastatin 80 MG (as atorvastatin calcium 82.73 MG) / ezetimibe 10 MG Oral TabletSY6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
2611248Lypqozet (atorvastatin 10 MG (as atorvastatin calcium 10.34 MG) / ezetimibe 10 MG) Oral TabletSY6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
2611250Lypqozet (atorvastatin 20 MG (as atorvastatin calcium 20.68 MG) / ezetimibe 10 MG) Oral TabletSY6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
2611252Lypqozet (atorvastatin 40 MG (as atorvastatin calcium 41.37 MG) / ezetimibe 10 MG) Oral TabletSY6375eae7-e159-4fb2-a91c-9aa20ac3c9e12
2611254Lypqozet (atorvastatin 80 MG (as atorvastatin calcium 82.73 MG) / ezetimibe 10 MG) Oral TabletSY6375eae7-e159-4fb2-a91c-9aa20ac3c9e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70661-006-307066100063030 TABLET in 1 BOTTLE (70661-006-30) 30 tablet2021-01-140000-00-00NoNoCurrent
70661-006-907066100069090 TABLET in 1 BOTTLE (70661-006-90) 90 tablet2021-01-140000-00-00NoNoCurrent