Home NDC 63850-0021 Trihexyphenidyl Hydrochloride
Product NDC 63850-0021
11-digit product format 638500021
Labeler code 63850
Product ID 63850-0021_2b77cfd6-ad8a-4cbf-a22c-eb69e7a8548c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trihexyphenidyl Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Natco Pharma Limited
Application ANDA091630
Marketing category ANDA
Marketing start 2010-10-17
Substance TRIHEXYPHENIDYL HYDROCHLORIDE
Active strength 2 mg/1
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 43 .
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 A091630-001 TRIHEXYPHENIDYL HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 2010-11-17 A091630-002 TRIHEXYPHENIDYL HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 2010-11-17
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 · 86 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 2026-09-14 22:38:34 2026-08 A091630-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 2010-11-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091630-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 2010-11-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091630-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 2010-11-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091630-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 2010-11-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091630-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 2010-11-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091630-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 2010-11-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091630-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 2010-11-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091630-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 2010-11-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091630-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 2010-11-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091630-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 2010-11-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091630-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 2010-11-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091630-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 2010-11-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091630-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 2010-11-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091630-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 2010-11-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091630-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 2010-11-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091630-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 2010-11-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091630-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 2010-11-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091630-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 2010-11-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091630-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 2010-11-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091630-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 2010-11-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091630-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 2010-11-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091630-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 2010-11-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091630-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 2010-11-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091630-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 2010-11-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091630-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 2010-11-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091630-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 2010-11-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091630-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 2010-11-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091630-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 2010-11-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091630-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 2010-11-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091630-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 2010-11-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091630-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 2010-11-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091630-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 2010-11-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091630-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 2010-11-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091630-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 2010-11-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091630-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 2010-11-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091630-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 2010-11-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091630-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 2010-11-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091630-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 2010-11-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091630-001 TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLET / ORAL AA 2010-11-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091630-002 TRIHEXYPHENIDYL HYDROCHLORIDE 5MG TABLET / ORAL AA 2010-11-17 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Trihexyphenidyl Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIHEXYPHENIDYL HYDROCHLORIDE 2 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 905269 Internal RxNorm lookup 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 63850-0021-1 Trihexyphenidyl Hydrochloride 100 in 1 BOTTLE TABLET 100 2 63850-0021-2 Trihexyphenidyl Hydrochloride 250 in 1 BOTTLE TABLET 250 2 63850-0021-3 Trihexyphenidyl Hydrochloride 1000 in 1 BOTTLE TABLET 1000 2
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63850-0021 TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [NATCO PHARMA LIMITED] 2 Current NDC, Legacy NDC, 3 package rows 20191101_b7e4200c-feff-4537-aad1-cf9989fd8c14.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 63850-0021-1 63850002101 100 TABLET in 1 BOTTLE (63850-0021-1) 100 tablet 2010-10-17 0000-00-00 No No Current 63850-0021-2 63850002102 250 TABLET in 1 BOTTLE (63850-0021-2) 250 tablet 2010-10-17 0000-00-00 No No Current 63850-0021-3 63850002103 1000 TABLET in 1 BOTTLE (63850-0021-3) 1000 tablet 2010-10-17 0000-00-00 No No Current