Home NDC 33342-013 Efavirenz
Product NDC 33342-013
11-digit product format 333420013
Labeler code 33342
Product ID 33342-013_f1a4251a-e04d-48aa-ae58-44b30df1de0d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Efavirenz
Dosage form TABLET
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA091579
Marketing category ANDA
Marketing start 2024-05-10
Substance EFAVIRENZ
Active strength 600 mg/1
Pharmacologic classes 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]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091579-001 EFAVIRENZ EFAVIRENZ 600MG TABLET / ORAL AB 2024-05-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091579-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A091579-001 EFAVIRENZ 600MG TABLET / ORAL AB 2024-05-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091579-001 EFAVIRENZ 600MG TABLET / ORAL AB 2024-05-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091579-001 EFAVIRENZ 600MG TABLET / ORAL AB 2024-05-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091579-001 EFAVIRENZ 600MG TABLET / ORAL AB 2024-05-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091579-001 EFAVIRENZ 600MG TABLET / ORAL AB 2024-05-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091579-001 EFAVIRENZ 600MG TABLET / ORAL AB 2024-05-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091579-001 EFAVIRENZ 600MG TABLET / ORAL AB 2024-05-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091579-001 EFAVIRENZ 600MG TABLET / ORAL AB 2024-05-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091579-001 EFAVIRENZ 600MG TABLET / ORAL AB 2024-05-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091579-001 EFAVIRENZ 600MG TABLET / ORAL AB 2024-05-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091579-001 EFAVIRENZ 600MG TABLET / ORAL AB 2024-05-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091579-001 EFAVIRENZ 600MG TABLET / ORAL AB 2024-05-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091579-001 EFAVIRENZ 600MG TABLET / ORAL AB 2024-05-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091579-001 EFAVIRENZ 600MG TABLET / ORAL AB 2024-05-10 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A091579-001 EFAVIRENZ 600MG TABLET / ORAL AB 2024-05-10 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Efavirenz
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EFAVIRENZ 600 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JE6H2O27P8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349477 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 33342-013-07 Efavirenz 30 in 1 BOTTLE TABLET 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-013 EFAVIRENZ TABLET [MACLEODS PHARMACEUTICALS LIMITED] 2 Current NDC, 1 package rows 20240630_13ca3456-e5bf-4bb1-af95-b1378658a358.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 33342-013-07 33342001307 30 TABLET in 1 BOTTLE (33342-013-07) 30 tablet 2024-05-10 No No Current