FDA.reportPublic FDA data

nevirapine

Product NDC
53104-0166
11-digit product format
531040166
Labeler code
53104
Product ID
53104-0166_caf42378-e171-46e5-9fd5-c02a9823616e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nevirapine
Dosage form
TABLET
Route
ORAL
Labeler
Cipla Ltd.
Application
ANDA077956
Marketing category
ANDA
Marketing start
2012-05-22
Marketing end
0000-00-00
Substance
NEVIRAPINE
Active strength
200 mg/1
Pharmacologic classes
Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [EXT],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a1bab0e5-3c0a-775a-2f29-a19e4e281871Product name320190610
d07e0b9e-e041-41dc-942a-a2a6601dc221Product name120181029
0d48f664-b8cd-5c4b-aa8e-0a00f1c0002dProduct name820171204

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53104-0166-22020-01-31C16284748780-19d75b9d0-145c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NEVIRAPINE TABLETS safely and effectively. See full prescribing information for NEVIRAPINE TABLETS. NEVIRAPINE Tablets USP, 200 mg, for oral use Initial U.S. Approval: 1996
53104-0166-62020-01-31C16284748780-19d75b9d0-145c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NEVIRAPINE TABLETS safely and effectively. See full prescribing information for NEVIRAPINE TABLETS. NEVIRAPINE Tablets USP, 200 mg, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53104-0166-2nevirapine60 in 1 BOTTLETABLET606
53104-0166-6nevirapine1000 in 1 BOTTLETABLET10006

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NEVIRAPINEACTIVE INGREDIENT99DK7FVK1HNEVIRAPINE TABLET [CIPLA LIMITED]2
NEVIRAPINEACTIVE MOIETY99DK7FVK1HNEVIRAPINE TABLET [CIPLA LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNEVIRAPINE TABLET [CIPLA LIMITED]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNEVIRAPINE TABLET [CIPLA LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NEVIRAPINE TABLET [CIPLA LIMITED]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NEVIRAPINE TABLET [CIPLA LIMITED]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNEVIRAPINE TABLET [CIPLA LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53104-0166NEVIRAPINE TABLET [CIPLA LTD.]6Legacy NDC, 2 package rows20181218_4d056e75-6122-4733-96cc-b21c7c944192.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199422nevirapine 200 MG Oral TabletPSN4d056e75-6122-4733-96cc-b21c7c9441926
199422nevirapine 200 MG Oral TabletSCD4d056e75-6122-4733-96cc-b21c7c9441926

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53104-0166-25310401660260 in 1 BOTTLEHistorical
53104-0166-6531040166061000 in 1 BOTTLEHistorical