nevirapine

Generic: nevirapine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nevirapine
Generic Name nevirapine
Labeler aurobindo pharma limited
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

nevirapine hemihydrate 50 mg/5mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-057
Product ID 65862-057_fd37e474-7411-4466-bf46-36fc74ef6684
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077702
Listing Expiration 2026-12-31
Marketing Start 2012-05-22

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862057
Hyphenated Format 65862-057

Supplemental Identifiers

RxCUI
311943
UNII
B7XF2TD73C

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 ANDA077702 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/5mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (65862-057-11)
  • 240 mL in 1 BOTTLE (65862-057-24)
source: ndc

Packages (2)

65862-057-11 100 mL in 1 BOTTLE (65862-057-11) 65862-057-24 240 mL in 1 BOTTLE (65862-057-24)

Ingredients (1)

nevirapine hemihydrate (50 mg/5mL)

Linked Drug Pages (1)

Nevirapine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fd37e474-7411-4466-bf46-36fc74ef6684", "openfda": {"unii": ["B7XF2TD73C"], "rxcui": ["311943"], "spl_set_id": ["8dfe86aa-ea5d-48d2-94a8-1a5506055d70"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (65862-057-11)", "package_ndc": "65862-057-11", "marketing_start_date": "20120522"}, {"sample": false, "description": "240 mL in 1 BOTTLE (65862-057-24)", "package_ndc": "65862-057-24", "marketing_start_date": "20120522"}], "brand_name": "Nevirapine", "product_id": "65862-057_fd37e474-7411-4466-bf46-36fc74ef6684", "dosage_form": "SUSPENSION", "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": "65862-057", "generic_name": "Nevirapine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nevirapine", "active_ingredients": [{"name": "NEVIRAPINE HEMIHYDRATE", "strength": "50 mg/5mL"}], "application_number": "ANDA077702", "marketing_category": "ANDA", "marketing_start_date": "20120522", "listing_expiration_date": "20261231"}