FDA.reportPublic FDA data

Nevirapine

Product NDC
0378-4050
11-digit product format
003784050
Labeler code
0378
Product ID
0378-4050_af4a1dc3-d150-42dc-95ab-89d579f1725a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nevirapine
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA202523
Marketing category
ANDA
Marketing start
2012-05-22
Substance
NEVIRAPINE
Active strength
200 mg/1
Pharmacologic classes
Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nevirapine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEVIRAPINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii99DK7FVK1H
Rxcui199422

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-4050-91Nevirapine60 in 1 BOTTLE, PLASTICTABLET6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-4050-91EA - Each0378-4050ab113b39-b2d1-4903-9ef4-7d35e3c172f312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NEVIRAPINEACTIVE INGREDIENT99DK7FVK1HNEVIRAPINE TABLET [MYLAN PHARMACEUTICALS INC.]4
NEVIRAPINEACTIVE MOIETY99DK7FVK1HNEVIRAPINE TABLET [MYLAN PHARMACEUTICALS INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNEVIRAPINE TABLET [MYLAN PHARMACEUTICALS INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNEVIRAPINE TABLET [MYLAN PHARMACEUTICALS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NEVIRAPINE TABLET [MYLAN PHARMACEUTICALS INC.]4
POVIDONESINACTIVE INGREDIENTFZ989GH94ENEVIRAPINE TABLET [MYLAN PHARMACEUTICALS INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NEVIRAPINE TABLET [MYLAN PHARMACEUTICALS INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NEVIRAPINE TABLET [MYLAN PHARMACEUTICALS INC.]4
NEVIRAPINEACTIVE INGREDIENT99DK7FVK1HNEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
NEVIRAPINEACTIVE MOIETY99DK7FVK1HNEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ENEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-4050NEVIRAPINE TABLET [MYLAN PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 1 package rows20240612_c6e93829-7024-48f6-8023-da6ff27dfc0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199422nevirapine 200 MG Oral TabletPSNc6e93829-7024-48f6-8023-da6ff27dfc0a10
199422nevirapine 200 MG Oral TabletSCDc6e93829-7024-48f6-8023-da6ff27dfc0a10
199422nevirapine 200 MG Oral TabletPSNe6267bd6-dd60-48d7-969c-c3ebaf113eb71
199422nevirapine 200 MG Oral TabletSCDe6267bd6-dd60-48d7-969c-c3ebaf113eb71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-4050-910037840509160 TABLET in 1 BOTTLE, PLASTIC (0378-4050-91) 60 tablet2012-05-220000-00-00NoNoCurrent