Home NDC 42385-999 Rilpivirine
Product NDC 42385-999
11-digit product format 423850999
Labeler code 42385
Product ID 42385-999_dadbf50d-6b7d-4fb5-bd9f-7769b048e764
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rilpivirine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Laurus Labs Limited
Application ANDA219788
Marketing category ANDA
Marketing start 2026-07-10
Substance RILPIVIRINE HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A219788-001 RILPIVIRINE HYDROCHLORIDE RILPIVIRINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2026-07-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219788-001 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 2026-09-14 22:38:34 2026-08 A219788-001 RILPIVIRINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2026-07-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219788-001 RILPIVIRINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2026-07-10 caaa826d4ba7…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A219788-001 AB 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219788-001 AB 1 caaa826d4ba7…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Rilpivirine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RILPIVIRINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 212WAX8KDD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1102273 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42385-999-30 42385099930 30 TABLET, FILM COATED in 1 BOTTLE (42385-999-30) 2026-07-10 No No Current 42385-999-31 42385099931 30 TABLET, FILM COATED in 1 BOTTLE (42385-999-31) 2026-07-10 No No Current