FDA.reportPublic FDA data

Nevirapine

Product NDC
65862-027
11-digit product format
658620027
Labeler code
65862
Product ID
65862-027_0f465f42-d781-453e-ac8c-f5017bf06fe1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nevirapine
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA077521
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
65862-027-10Nevirapine10 in 1 BLISTER PACKTABLET109
65862-027-10Nevirapine6 in 1 CARTONTABLET69
65862-027-60Nevirapine60 in 1 BOTTLETABLET609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-027-60EA - Each65862-0276b273486-ec5c-4a17-b0d9-758e01ae723312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NEVIRAPINEACTIVE INGREDIENT99DK7FVK1HNEVIRAPINE TABLET [AUROBINDO PHARMA LIMITED]4
NEVIRAPINEACTIVE MOIETY99DK7FVK1HNEVIRAPINE TABLET [AUROBINDO PHARMA LIMITED]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNEVIRAPINE TABLET [AUROBINDO PHARMA LIMITED]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNEVIRAPINE TABLET [AUROBINDO PHARMA LIMITED]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NEVIRAPINE TABLET [AUROBINDO PHARMA LIMITED]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XNEVIRAPINE TABLET [AUROBINDO PHARMA LIMITED]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NEVIRAPINE TABLET [AUROBINDO PHARMA LIMITED]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NEVIRAPINE TABLET [AUROBINDO PHARMA LIMITED]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-027NEVIRAPINE TABLET [AUROBINDO PHARMA LIMITED]9Current NDC, Legacy NDC, 3 package rows20240521_5f6c3eed-2a5d-46ed-9a7c-59715f338a15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199422nevirapine 200 MG Oral TabletPSN5f6c3eed-2a5d-46ed-9a7c-59715f338a159
199422nevirapine 200 MG Oral TabletSCD5f6c3eed-2a5d-46ed-9a7c-59715f338a159

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-027-10658620027106 BLISTER PACK in 1 CARTON (65862-027-10) / 10 TABLET in 1 BLISTER PACK6 blister pack2012-05-220000-00-00NoNoCurrent
65862-027-606586200276060 TABLET in 1 BOTTLE (65862-027-60) 60 tablet2012-05-220000-00-00NoNoCurrent