Home NDC 0378-3432 Armodafinil
Product NDC 0378-3432
11-digit product format 003783432
Labeler code 0378
Product ID 0378-3432_34fcca9f-37ba-40d9-9032-6ffeeb031a36
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name armodafinil
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
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 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 · 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.
Product history page 1 of 6 · 210 observed 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 A200043-001 ARMODAFINIL 50MG TABLET / ORAL AB 2012-06-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200043-002 ARMODAFINIL 150MG TABLET / ORAL AB 2012-06-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200043-003 ARMODAFINIL 250MG TABLET / ORAL AB 2012-06-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200043-004 ARMODAFINIL 100MG TABLET / ORAL AB 2019-05-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200043-005 ARMODAFINIL 200MG TABLET / ORAL AB 2019-05-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200043-001 ARMODAFINIL 50MG TABLET / ORAL AB 2012-06-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200043-002 ARMODAFINIL 150MG TABLET / ORAL AB 2012-06-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200043-003 ARMODAFINIL 250MG TABLET / ORAL AB 2012-06-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200043-004 ARMODAFINIL 100MG TABLET / ORAL AB 2019-05-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200043-005 ARMODAFINIL 200MG TABLET / ORAL AB 2019-05-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200043-001 ARMODAFINIL 50MG TABLET / ORAL AB 2012-06-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200043-002 ARMODAFINIL 150MG TABLET / ORAL AB 2012-06-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200043-003 ARMODAFINIL 250MG TABLET / ORAL AB 2012-06-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200043-004 ARMODAFINIL 100MG TABLET / ORAL AB 2019-05-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200043-005 ARMODAFINIL 200MG TABLET / ORAL AB 2019-05-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200043-001 ARMODAFINIL 50MG TABLET / ORAL AB 2012-06-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200043-002 ARMODAFINIL 150MG TABLET / ORAL AB 2012-06-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200043-003 ARMODAFINIL 250MG TABLET / ORAL AB 2012-06-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200043-004 ARMODAFINIL 100MG TABLET / ORAL AB 2019-05-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200043-005 ARMODAFINIL 200MG TABLET / ORAL AB 2019-05-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200043-001 ARMODAFINIL 50MG TABLET / ORAL AB 2012-06-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200043-002 ARMODAFINIL 150MG TABLET / ORAL AB 2012-06-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200043-003 ARMODAFINIL 250MG TABLET / ORAL AB 2012-06-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200043-004 ARMODAFINIL 100MG TABLET / ORAL AB 2019-05-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200043-005 ARMODAFINIL 200MG TABLET / ORAL AB 2019-05-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200043-001 ARMODAFINIL 50MG TABLET / ORAL AB 2012-06-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200043-002 ARMODAFINIL 150MG TABLET / ORAL AB 2012-06-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200043-003 ARMODAFINIL 250MG TABLET / ORAL AB 2012-06-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200043-004 ARMODAFINIL 100MG TABLET / ORAL AB 2019-05-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200043-005 ARMODAFINIL 200MG TABLET / ORAL AB 2019-05-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200043-001 ARMODAFINIL 50MG TABLET / ORAL AB 2012-06-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200043-002 ARMODAFINIL 150MG TABLET / ORAL AB 2012-06-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200043-003 ARMODAFINIL 250MG TABLET / ORAL AB 2012-06-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200043-004 ARMODAFINIL 100MG TABLET / ORAL AB 2019-05-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200043-005 ARMODAFINIL 200MG TABLET / ORAL AB 2019-05-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200043-001 ARMODAFINIL 50MG TABLET / ORAL AB 2012-06-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200043-002 ARMODAFINIL 150MG TABLET / ORAL AB 2012-06-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200043-003 ARMODAFINIL 250MG TABLET / ORAL AB 2012-06-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200043-004 ARMODAFINIL 100MG TABLET / ORAL AB 2019-05-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200043-005 ARMODAFINIL 200MG TABLET / ORAL AB 2019-05-09 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 210 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Armodafinil
Listing expiration 2026-12-31 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 724859 Internal RxNorm lookup 724861 Internal RxNorm lookup 724863 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 0378-3432-93 Armodafinil 30 in 1 BOTTLE, PLASTIC TABLET 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-3432 ARMODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 1 package rows 20240712_de0799f7-7644-4057-a7da-75436f978c61.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0378-3432-93 00378343293 30 TABLET in 1 BOTTLE, PLASTIC (0378-3432-93) 30 tablet 2016-06-01 0000-00-00 No No Current