Nevirapine

Product NDC
33342-004
11-digit product format
333420004
Labeler code
33342
Product ID
33342-004_99d52ed2-f3e5-476a-8ba6-ed2cee3aae8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nevirapine
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA090688
Marketing category
ANDA
Marketing start
2019-01-28
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
33342-004-09Nevirapine60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-004-09EA - Each33342-0041e5ddcb6-519e-4c40-86e2-d308a0ac804c12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-004NEVIRAPINE TABLET [MACLEODS PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 1 package rows20230817_effb86cc-4b80-4fac-aaa3-9f373b3d0f7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199422nevirapine 200 MG Oral TabletPSNeffb86cc-4b80-4fac-aaa3-9f373b3d0f7d3
199422nevirapine 200 MG Oral TabletSCDeffb86cc-4b80-4fac-aaa3-9f373b3d0f7d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-004-093334200040960 TABLET in 1 BOTTLE (33342-004-09) 60 tablet2019-01-280000-00-00NoNoCurrent
33342-004-24333420004246 BLISTER PACK in 1 CARTON (33342-004-24) > 10 TABLET in 1 BLISTER PACK6 blister pack2019-01-280000-00-00NoNoCurrent
33342-004-253334200042512 BLISTER PACK in 1 CARTON (33342-004-25) > 10 TABLET in 1 BLISTER PACK12 blister pack2019-01-280000-00-00NoNoCurrent