Home NDC 71335-2991-2 Armodafinil
Product NDC 71335-2991
Requested package NDC 71335-2991-2
11-digit product format 713352991
Labeler code 71335
Product ID 71335-2991_7e8152cc-4061-4276-8843-a06cbfb5b1bf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name armodafinil
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA200043
Marketing category ANDA
Marketing start 2016-06-01
Substance ARMODAFINIL
Active strength 150 mg/1
DEA schedule CIV
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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A200043-001 ARMODAFINIL ARMODAFINIL 50MG TABLET / ORAL AB 2012-06-01 A200043-002 ARMODAFINIL ARMODAFINIL 150MG TABLET / ORAL AB 2012-06-01 A200043-003 ARMODAFINIL ARMODAFINIL 250MG TABLET / ORAL AB 2012-06-01 A200043-004 ARMODAFINIL ARMODAFINIL 100MG TABLET / ORAL AB 2019-05-09 A200043-005 ARMODAFINIL ARMODAFINIL 200MG TABLET / ORAL AB 2019-05-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
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 2026-08-01 22:54:32 2026-06 A200043-001 ARMODAFINIL 50MG TABLET / ORAL AB 2012-06-01 a50c72e98297…2026-08-01 22:54:32 2026-06 A200043-002 ARMODAFINIL 150MG TABLET / ORAL AB 2012-06-01 a50c72e98297…2026-08-01 22:54:32 2026-06 A200043-003 ARMODAFINIL 250MG TABLET / ORAL AB 2012-06-01 a50c72e98297…2026-08-01 22:54:32 2026-06 A200043-004 ARMODAFINIL 100MG TABLET / ORAL AB 2019-05-09 a50c72e98297…2026-08-01 22:54:32 2026-06 A200043-005 ARMODAFINIL 200MG TABLET / ORAL AB 2019-05-09 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Armodafinil
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ARMODAFINIL 150 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V63XWA605I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 724859 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 71335-2991-1 Armodafinil 30 in 1 BOTTLE TABLET 30 1 71335-2991-2 Armodafinil 28 in 1 BOTTLE TABLET 28 1 71335-2991-3 Armodafinil 90 in 1 BOTTLE TABLET 90 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71335-2991-2 71335299102 28 TABLET in 1 BOTTLE (71335-2991-2) 28 tablet 2026-02-04 No No Current