Home NDC 31722-505-60 Nevirapine
Product NDC 31722-505
Requested package NDC 31722-505-60
11-digit product format 317220505
Labeler code 31722
Product ID 31722-505_e5515515-0ee0-e288-e053-2995a90a3d7c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nevirapine
Dosage form TABLET
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA078584
Marketing category ANDA
Marketing start 2012-05-23
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078584-001 NEVIRAPINE NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078584-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A078584-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Nevirapine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NEVIRAPINE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 99DK7FVK1H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199422 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 31722-505-01 Nevirapine 100 in 1 BOTTLE TABLET 100 15 31722-505-05 Nevirapine 500 in 1 BOTTLE TABLET 500 15 31722-505-10 Nevirapine 1000 in 1 BOTTLE TABLET 1000 15 31722-505-60 Nevirapine 60 in 1 BOTTLE TABLET 60 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NEVIRAPINE ACTIVE INGREDIENT 99DK7FVK1H NEVIRAPINE TABLET [CAMBER PHARMACEUTICALS, INC.] 8 NEVIRAPINE ACTIVE MOIETY 99DK7FVK1H NEVIRAPINE TABLET [CAMBER PHARMACEUTICALS, INC.] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NEVIRAPINE TABLET [CAMBER PHARMACEUTICALS, INC.] 8 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NEVIRAPINE TABLET [CAMBER PHARMACEUTICALS, INC.] 8 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NEVIRAPINE TABLET [CAMBER PHARMACEUTICALS, INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NEVIRAPINE TABLET [CAMBER PHARMACEUTICALS, INC.] 8 POVIDONE INACTIVE INGREDIENT FZ989GH94E NEVIRAPINE TABLET [CAMBER PHARMACEUTICALS, INC.] 8 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 NEVIRAPINE TABLET [CAMBER PHARMACEUTICALS, INC.] 8 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NEVIRAPINE TABLET [CAMBER PHARMACEUTICALS, INC.] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-505 NEVIRAPINE (NEVIRAPINE) TABLET [CAMBER PHARMACEUTICALS, INC.] 15 Current NDC, Legacy NDC, 4 package rows 20220805_61409678-d2f6-42cd-b03d-b26b11b39641.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 31722-505-60 31722050560 60 TABLET in 1 BOTTLE (31722-505-60) 60 tablet 2012-05-23 0000-00-00 No No Current