Home NDC 70518-2409-2 TRIHEXYPHENIDYL HYDROCHLORIDE
Product NDC 70518-2409
Requested package NDC 70518-2409-2
11-digit product format 705182409
Labeler code 70518
Product ID 70518-2409_4a17b684-8b80-215c-e063-6394a90a6e19
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TRIHEXYPHENIDYL HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA040254
Marketing category ANDA
Marketing start 2019-11-08
Substance TRIHEXYPHENIDYL HYDROCHLORIDE
Active strength 5 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
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 A040254-001 TRIHEXYPHENIDYL HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 1998-12-24 A040254-002 TRIHEXYPHENIDYL HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 1998-12-24
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 A040254-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 1998-12-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040254-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 1998-12-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040254-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 1998-12-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040254-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 1998-12-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040254-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 1998-12-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040254-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 1998-12-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040254-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 1998-12-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040254-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 1998-12-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040254-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 1998-12-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040254-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 1998-12-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040254-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 1998-12-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040254-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 1998-12-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040254-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 1998-12-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040254-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 1998-12-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040254-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 1998-12-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040254-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 1998-12-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040254-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 1998-12-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040254-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 1998-12-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040254-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 1998-12-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040254-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 1998-12-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040254-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 1998-12-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040254-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 1998-12-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040254-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 1998-12-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040254-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 1998-12-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040254-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 1998-12-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040254-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 1998-12-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040254-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 1998-12-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040254-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 1998-12-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040254-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 1998-12-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040254-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 1998-12-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040254-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 1998-12-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040254-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 1998-12-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040254-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 1998-12-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040254-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 1998-12-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040254-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 1998-12-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040254-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 1998-12-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040254-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 1998-12-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040254-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 1998-12-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040254-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 1998-12-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040254-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 1998-12-24 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 TRIHEXYPHENIDYL HYDROCHLORIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination AO61G82577 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 905283 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 70518-2409-0 TRIHEXYPHENIDYL HYDROCHLORIDE 100 in 1 BOX TABLET 100 12 70518-2409-1 TRIHEXYPHENIDYL HYDROCHLORIDE 1 in 1 POUCH TABLET 1 12 70518-2409-2 TRIHEXYPHENIDYL HYDROCHLORIDE 100 in 1 BOX TABLET 100 12 70518-2409-3 TRIHEXYPHENIDYL HYDROCHLORIDE 1 in 1 POUCH TABLET 1 12 70518-2409-4 TRIHEXYPHENIDYL HYDROCHLORIDE 30 in 1 BLISTER PACK TABLET 30 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-2409 TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [REMEDYREPACK INC.] 10 Current NDC, Legacy NDC, 5 package rows 20250521_c25ea809-5bdf-4917-97f1-610059fbd0b7.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 · 4 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 70518-2409-2 70518240902 100 POUCH in 1 BOX (70518-2409-2) / 1 TABLET in 1 POUCH (70518-2409-3) 100 pouch 2021-05-11 0000-00-00 No No Current