FDA.reportPublic FDA data

NEVIRAPINE

Product NDC
33342-238
11-digit product format
333420238
Labeler code
33342
Product ID
33342-238_de3914b8-5c5c-4b11-a9f9-39f592d51c1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NEVIRAPINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA206879
Marketing category
ANDA
Marketing start
2017-10-07
Substance
NEVIRAPINE
Active strength
400 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
NEVIRAPINE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii99DK7FVK1H
Rxcui1095712

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
33342-238-07NEVIRAPINE30 in 1 BOTTLETABLET, EXTENDED RELEASE306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-238-07EA - Each33342-23829303fc6-d3bb-41bf-8cbf-0fe3c2e8d19212018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-238NEVIRAPINE TABLET, EXTENDED RELEASE [MACLEODS PHARMACEUTICALS LIMITED]6Current NDC, Legacy NDC, 1 package rows20240824_2620b114-f53f-44f1-8708-697e86343090.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1095712nevirapine 400 MG 24HR Extended Release Oral TabletPSN2620b114-f53f-44f1-8708-697e863430906
109571224 HR nevirapine 400 MG Extended Release Oral TabletSCD2620b114-f53f-44f1-8708-697e863430906
1095712nevirapine 400 MG 24 HR Extended Release Oral TabletSY2620b114-f53f-44f1-8708-697e863430906

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-238-073334202380730 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-238-07) 2017-10-070000-00-00NoNoCurrent
33342-238-123334202381210 BLISTER PACK in 1 CARTON (33342-238-12) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2017-10-070000-00-00NoNoCurrent