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 CAPSULE
Routes
ORAL
Active Ingredients

efavirenz 200 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-106
Product ID 65862-106_a02dd4c8-6159-48b0-a79c-c362f1f4daf9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078064
Listing Expiration 2026-12-31
Marketing Start 2017-12-15

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 65862106
Hyphenated Format 65862-106

Supplemental Identifiers

RxCUI
205290 205291 205292
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 ANDA078064 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 9 BLISTER PACK in 1 CARTON (65862-106-09) / 10 CAPSULE in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (65862-106-10) / 10 CAPSULE in 1 BLISTER PACK
  • 30 CAPSULE in 1 BOTTLE (65862-106-30)
  • 90 CAPSULE in 1 BOTTLE (65862-106-90)
source: ndc

Packages (4)

65862-106-09 9 BLISTER PACK in 1 CARTON (65862-106-09) / 10 CAPSULE in 1 BLISTER PACK 65862-106-10 3 BLISTER PACK in 1 CARTON (65862-106-10) / 10 CAPSULE in 1 BLISTER PACK 65862-106-30 30 CAPSULE in 1 BOTTLE (65862-106-30) 65862-106-90 90 CAPSULE in 1 BOTTLE (65862-106-90)

Ingredients (1)

efavirenz (200 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": "a02dd4c8-6159-48b0-a79c-c362f1f4daf9", "openfda": {"nui": ["N0000175463", "N0000175460", "N0000009948", "N0000190118", "N0000187064", "N0000185504", "N0000182140", "N0000182141"], "unii": ["JE6H2O27P8"], "rxcui": ["205290", "205291", "205292"], "spl_set_id": ["4c57ad7f-321a-46c8-851a-c895466eb8e1"], "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": "9 BLISTER PACK in 1 CARTON (65862-106-09)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "65862-106-09", "marketing_start_date": "20171215"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (65862-106-10)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "65862-106-10", "marketing_start_date": "20171215"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (65862-106-30)", "package_ndc": "65862-106-30", "marketing_start_date": "20171215"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (65862-106-90)", "package_ndc": "65862-106-90", "marketing_start_date": "20171215"}], "brand_name": "Efavirenz", "product_id": "65862-106_a02dd4c8-6159-48b0-a79c-c362f1f4daf9", "dosage_form": "CAPSULE", "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": "65862-106", "generic_name": "Efavirenz", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Efavirenz", "active_ingredients": [{"name": "EFAVIRENZ", "strength": "200 mg/1"}], "application_number": "ANDA078064", "marketing_category": "ANDA", "marketing_start_date": "20171215", "listing_expiration_date": "20261231"}