Home NDC 70069-848 Rilpivirine
Product NDC 70069-848
11-digit product format 700690848
Labeler code 70069
Product ID 70069-848_8d833cc1-60b6-4e31-aff3-2958b8f93d1f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rilpivirine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Somerset Therapeutics, LLC
Application ANDA218798
Marketing category ANDA
Marketing start 2026-01-30
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 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 A218798-001 RILPIVIRINE HYDROCHLORIDE RILPIVIRINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2026-01-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218798-001 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 A218798-001 RILPIVIRINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2026-01-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218798-001 RILPIVIRINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2026-01-29 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218798-001 RILPIVIRINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2026-01-29 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A218798-001 AB 1 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218798-001 AB 1 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218798-001 AB 1 a50c72e98297…
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70069-848-30 Rilpivirine 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 70069-848-30 70069084830 30 TABLET, FILM COATED in 1 BOTTLE (70069-848-30) 2026-01-30 No No Current