Home NDC 71335-1402-9 Modafinil
Product NDC 71335-1402
Requested package NDC 71335-1402-9
11-digit product format 713351402
Labeler code 71335
Product ID 71335-1402_7e642144-a267-40b2-8684-a2cfbb7acc5f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Modafinil
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA078963
Marketing category ANDA
Marketing start 2013-08-01
Marketing end 0000-00-00
Substance MODAFINIL
Active strength 200 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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71335-1402 71335-1402-9 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71335-1402 71335-1402-9 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1402 MODAFINIL TABLET [BRYANT RANCH PREPACK] 3 Legacy NDC, 9 package rows 20231118_7e642144-a267-40b2-8684-a2cfbb7acc5f.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 71335-1402-9 71335140209 180 TABLET in 1 BOTTLE (71335-1402-9) 180 tablet 2022-02-14 0000-00-00 No No Current