efavirenz
Generic: efavirenz
Labeler: macleods pharmaceuticals limitedDrug Facts
Product Profile
Brand Name
efavirenz
Generic Name
efavirenz
Labeler
macleods pharmaceuticals limited
Dosage Form
TABLET
Routes
Active Ingredients
efavirenz 600 mg/1
Manufacturer
Identifiers & Regulatory
Product NDC
33342-013
Product ID
33342-013_f1a4251a-e04d-48aa-ae58-44b30df1de0d
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
ANDA
Application Number
ANDA091579
Listing Expiration
2026-12-31
Marketing Start
2024-05-10
Pharmacologic Class
Established (EPC)
Mechanism of Action
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
33342013
Hyphenated Format
33342-013
Supplemental Identifiers
RxCUI
UNII
NUI
Packaging Origin
Original Packager
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
ANDA091579 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 600 mg/1
Packaging
- 30 TABLET in 1 BOTTLE (33342-013-07)
Packages (1)
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "f1a4251a-e04d-48aa-ae58-44b30df1de0d", "openfda": {"nui": ["N0000175463", "N0000175460", "N0000009948", "N0000190118", "N0000187064", "N0000185504", "N0000182140", "N0000182141"], "unii": ["JE6H2O27P8"], "rxcui": ["349477"], "spl_set_id": ["13ca3456-e5bf-4bb1-af95-b1378658a358"], "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": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (33342-013-07)", "package_ndc": "33342-013-07", "marketing_start_date": "20240510"}], "brand_name": "Efavirenz", "product_id": "33342-013_f1a4251a-e04d-48aa-ae58-44b30df1de0d", "dosage_form": "TABLET", "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": "33342-013", "generic_name": "Efavirenz", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Efavirenz", "active_ingredients": [{"name": "EFAVIRENZ", "strength": "600 mg/1"}], "application_number": "ANDA091579", "marketing_category": "ANDA", "marketing_start_date": "20240510", "listing_expiration_date": "20261231"}