nevirapine

Generic: nevirapine

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nevirapine
Generic Name nevirapine
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

nevirapine 400 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-238
Product ID 33342-238_de3914b8-5c5c-4b11-a9f9-39f592d51c1d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206879
Listing Expiration 2026-12-31
Marketing Start 2017-10-07

Pharmacologic Class

Established (EPC)
human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitor [epc]
Mechanism of Action
non-nucleoside reverse transcriptase inhibitors [moa] cytochrome p450 3a inducers [moa] cytochrome p450 2b6 inducers [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342238
Hyphenated Format 33342-238

Supplemental Identifiers

RxCUI
1095712
UPC
0333342238078 0333342238122
UNII
99DK7FVK1H
NUI
N0000175463 N0000175460 N0000009948 N0000190118 N0000187064

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nevirapine (source: ndc)
Generic Name nevirapine (source: ndc)
Application Number ANDA206879 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-238-07)
source: ndc

Packages (1)

33342-238-07 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-238-07)

Ingredients (1)

nevirapine (400 mg/1)

Linked Drug Pages (1)

NEVIRAPINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "de3914b8-5c5c-4b11-a9f9-39f592d51c1d", "openfda": {"nui": ["N0000175463", "N0000175460", "N0000009948", "N0000190118", "N0000187064"], "upc": ["0333342238078", "0333342238122"], "unii": ["99DK7FVK1H"], "rxcui": ["1095712"], "spl_set_id": ["2620b114-f53f-44f1-8708-697e86343090"], "pharm_class_epc": ["Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-238-07)", "package_ndc": "33342-238-07", "marketing_start_date": "20171007"}], "brand_name": "NEVIRAPINE", "product_id": "33342-238_de3914b8-5c5c-4b11-a9f9-39f592d51c1d", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["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]"], "product_ndc": "33342-238", "generic_name": "NEVIRAPINE", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NEVIRAPINE", "active_ingredients": [{"name": "NEVIRAPINE", "strength": "400 mg/1"}], "application_number": "ANDA206879", "marketing_category": "ANDA", "marketing_start_date": "20171007", "listing_expiration_date": "20261231"}