Home NDC 71610-989 Modafinil
Product NDC 71610-989
11-digit product format 716100989
Labeler code 71610
Product ID 71610-989_4aa301e3-c34b-232a-e063-6394a90a86d1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Modafinil
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA078963
Marketing category ANDA
Marketing start 2022-02-28
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 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 · 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MODAFINIL 200 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 205324 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 71610-989-30 Modafinil 30 in 1 BOTTLE TABLET 30 1 71610-989-53 Modafinil 60 in 1 BOTTLE TABLET 60 1 71610-989-60 Modafinil 90 in 1 BOTTLE TABLET 90 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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71610-989-30 71610098930 30 TABLET in 1 BOTTLE (71610-989-30) 30 tablet 2026-02-10 No No Current 71610-989-53 71610098953 60 TABLET in 1 BOTTLE (71610-989-53) 60 tablet 2026-02-10 No No Current 71610-989-60 71610098960 90 TABLET in 1 BOTTLE (71610-989-60) 90 tablet 2026-02-10 No No Current