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, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

nevirapine 400 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-4890
Product ID 0378-4890_750bda83-d972-44e2-85ae-26676e1e7c34
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205651
Listing Expiration 2026-12-31
Marketing Start 2014-10-29

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 03784890
Hyphenated Format 0378-4890

Supplemental Identifiers

RxCUI
1095712
UPC
0303784890936
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 ANDA205651 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4890-93)
source: ndc

Packages (1)

0378-4890-93 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4890-93)

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": "750bda83-d972-44e2-85ae-26676e1e7c34", "openfda": {"nui": ["N0000175463", "N0000175460", "N0000009948", "N0000190118", "N0000187064"], "upc": ["0303784890936"], "unii": ["99DK7FVK1H"], "rxcui": ["1095712"], "spl_set_id": ["690da74b-2481-47fc-93ae-8340e0caf0a4"], "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": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4890-93)", "package_ndc": "0378-4890-93", "marketing_start_date": "20141029"}], "brand_name": "Nevirapine", "product_id": "0378-4890_750bda83-d972-44e2-85ae-26676e1e7c34", "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": "0378-4890", "generic_name": "nevirapine", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nevirapine", "active_ingredients": [{"name": "NEVIRAPINE", "strength": "400 mg/1"}], "application_number": "ANDA205651", "marketing_category": "ANDA", "marketing_start_date": "20141029", "listing_expiration_date": "20261231"}