efavirenz

Generic: efavirenz

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

Drug Facts

Product Profile

Brand Name efavirenz
Generic Name efavirenz
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

efavirenz 600 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-049
Product ID 65862-049_f9982eb1-1e15-4fad-99f9-0f9da04fd058
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077673
Listing Expiration 2026-12-31
Marketing Start 2018-09-21

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] cytochrome p450 2c9 inhibitors [moa] cytochrome p450 2c19 inhibitors [moa] cytochrome p450 3a4 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862049
Hyphenated Format 65862-049

Supplemental Identifiers

RxCUI
349477
UPC
0365862049100
UNII
JE6H2O27P8
NUI
N0000175463 N0000175460 N0000009948 N0000190118 N0000187064 N0000185504 N0000182140 N0000182141

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 efavirenz (source: ndc)
Generic Name efavirenz (source: ndc)
Application Number ANDA077673 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (65862-049-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-049-30)
source: ndc

Packages (2)

65862-049-10 3 BLISTER PACK in 1 CARTON (65862-049-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 65862-049-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-049-30)

Ingredients (1)

efavirenz (600 mg/1)

Linked Drug Pages (1)

Efavirenz ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f9982eb1-1e15-4fad-99f9-0f9da04fd058", "openfda": {"nui": ["N0000175463", "N0000175460", "N0000009948", "N0000190118", "N0000187064", "N0000185504", "N0000182140", "N0000182141"], "upc": ["0365862049100"], "unii": ["JE6H2O27P8"], "rxcui": ["349477"], "spl_set_id": ["c5eedb5d-4cab-4056-a14a-ffdf67701355"], "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]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (65862-049-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65862-049-10", "marketing_start_date": "20180921"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-049-30)", "package_ndc": "65862-049-30", "marketing_start_date": "20180921"}], "brand_name": "Efavirenz", "product_id": "65862-049_f9982eb1-1e15-4fad-99f9-0f9da04fd058", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Non-Nucleoside Analog [EXT]", "Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "65862-049", "generic_name": "Efavirenz", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Efavirenz", "active_ingredients": [{"name": "EFAVIRENZ", "strength": "600 mg/1"}], "application_number": "ANDA077673", "marketing_category": "ANDA", "marketing_start_date": "20180921", "listing_expiration_date": "20261231"}