Home NDC 69452-342 Modafinil
Product NDC 69452-342
11-digit product format 694520342
Labeler code 69452
Product ID 69452-342_45322b3a-fdbe-466f-a2d3-b64e12b36efe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Modafinil
Dosage form TABLET
Route ORAL
Labeler Bionpharma Inc.
Application ANDA078963
Marketing category ANDA
Marketing start 2022-02-28
Substance MODAFINIL
Active strength 100 mg/1
Pharmacologic classes Central Nervous System Stimulation [PE], Increased Sympathetic Activity [PE], Sympathomimetic-like Agent [EPC]
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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078963-001 MODAFINIL MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 A078963-002 MODAFINIL MODAFINIL 200MG TABLET / ORAL AB 2012-09-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078963-001 MODAFINIL 100MG TABLET / ORAL AB 2012-09-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078963-002 MODAFINIL 200MG TABLET / ORAL AB 2012-09-26 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Modafinil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MODAFINIL 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R3UK8X3U3D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 205324 Internal RxNorm lookup 260218 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 69452-342-13 Modafinil 30 in 1 BOTTLE, PLASTIC TABLET 30 2 69452-342-19 Modafinil 90 in 1 BOTTLE, PLASTIC TABLET 90 2 69452-342-20 Modafinil 100 in 1 BOTTLE, PLASTIC TABLET 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-342 MODAFINIL TABLET [BIONPHARMA INC.] 2 Current NDC, Legacy NDC, 3 package rows 20231109_63604fef-0b80-40ce-8dbf-3384f1aee395.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 · 3 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 69452-342-13 69452034213 30 TABLET in 1 BOTTLE, PLASTIC (69452-342-13) 30 tablet 2022-02-28 0000-00-00 No No Current 69452-342-19 69452034219 90 TABLET in 1 BOTTLE, PLASTIC (69452-342-19) 90 tablet 2022-02-28 0000-00-00 No No Current 69452-342-20 69452034220 100 TABLET in 1 BOTTLE, PLASTIC (69452-342-20) 100 tablet 2022-02-28 0000-00-00 No No Current