Viramune

Product NDC
0597-0123
11-digit product format
005970123
Labeler code
0597
Product ID
0597-0123_d0510975-fd94-4b47-b5c4-a8babe77a6fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nevirapine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
Application
NDA201152
Marketing category
NDA
Marketing start
2011-04-11
Marketing end
2023-02-28
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
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0123-30EA - Each0597-0123217a7272-afa6-4e2d-88da-5faa55cf4b6812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NEVIRAPINEACTIVE INGREDIENT99DK7FVK1HVIRAMUNE (NEVIRAPINE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
NEVIRAPINEACTIVE MOIETY99DK7FVK1HVIRAMUNE (NEVIRAPINE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0597-0123-300059701233030 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0123-30) 2011-04-110000-00-00NoNoCurrent