Home NDC 42385-801 emtricitabine, rilpivirine and tenofovir disoproxil fumarate
Product NDC 42385-801
11-digit product format 423850801
Labeler code 42385
Product ID 42385-801_7193c90e-456c-4cfb-8181-65a1618dae51
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name emtricitabine, rilpivirine and tenofovir disoproxil fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Laurus Labs Limited
Application ANDA220232
Marketing category ANDA
Marketing start 2026-03-05
Substance EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
Active strength 200; 25; 300 mg/1; mg/1; mg/1
Pharmacologic classes Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A220232-001 EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE 200MG;EQ 25MG BASE;300MG TABLET / ORAL AB 2026-03-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220232-001 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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220232-001 EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE 200MG;EQ 25MG BASE;300MG TABLET / ORAL AB 2026-03-04 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220232-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base emtricitabine, rilpivirine and tenofovir disoproxil fumarate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EMTRICITABINE 200 mg/1 RILPIVIRINE HYDROCHLORIDE 25 mg/1 TENOFOVIR DISOPROXIL FUMARATE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G70B4ETF4S Internal UNII lookup 212WAX8KDD Internal UNII lookup OTT9J7900I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1147334 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 42385-801-30 emtricitabine, rilpivirine and tenofovir disoproxil fumarate 30 in 1 BOTTLE TABLET, FILM COATED 30 1
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 Marketing start Sample Exclude flag Status 42385-801-30 42385080130 30 TABLET, FILM COATED in 1 BOTTLE (42385-801-30) 2026-03-05 No No Current