nevirapine

Generic: nevirapine

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nevirapine
Generic Name nevirapine
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

nevirapine 200 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-4050
Product ID 0378-4050_af4a1dc3-d150-42dc-95ab-89d579f1725a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202523
Listing Expiration 2026-12-31
Marketing Start 2012-05-22

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 03784050
Hyphenated Format 0378-4050

Supplemental Identifiers

RxCUI
199422
UPC
0303784050910
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 ANDA202523 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE, PLASTIC (0378-4050-91)
source: ndc

Packages (1)

0378-4050-91 60 TABLET in 1 BOTTLE, PLASTIC (0378-4050-91)

Ingredients (1)

nevirapine (200 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": "af4a1dc3-d150-42dc-95ab-89d579f1725a", "openfda": {"nui": ["N0000175463", "N0000175460", "N0000009948", "N0000190118", "N0000187064"], "upc": ["0303784050910"], "unii": ["99DK7FVK1H"], "rxcui": ["199422"], "spl_set_id": ["c6e93829-7024-48f6-8023-da6ff27dfc0a"], "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": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (0378-4050-91)", "package_ndc": "0378-4050-91", "marketing_start_date": "20120522"}], "brand_name": "Nevirapine", "product_id": "0378-4050_af4a1dc3-d150-42dc-95ab-89d579f1725a", "dosage_form": "TABLET", "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": "0378-4050", "generic_name": "nevirapine", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nevirapine", "active_ingredients": [{"name": "NEVIRAPINE", "strength": "200 mg/1"}], "application_number": "ANDA202523", "marketing_category": "ANDA", "marketing_start_date": "20120522", "listing_expiration_date": "20261231"}