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 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
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.

Application-product, TE code table
Application-product	TE code
A091630-001	AA
A091630-002	AA

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	Approval date	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091630-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091630-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091630-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091630-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091630-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091630-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091630-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091630-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091630-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091630-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091630-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091630-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091630-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091630-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091630-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091630-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091630-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091630-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091630-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091630-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091630-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091630-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091630-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091630-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091630-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091630-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091630-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091630-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091630-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091630-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091630-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091630-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091630-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091630-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091630-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091630-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091630-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091630-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091630-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091630-002	AA	1	`782e0a99824c…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b7e4200c-feff-4537-aad1-cf9989fd8c14	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ca4f09e5-cb3a-0be2-bbd8-d34d4562feda	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRIHEXYPHENIDYL HYDROCHLORIDE	ACTIVE INGREDIENT	AO61G82577	TRIHEXYPHENIDYL HYDROCHLORIDE (TRIHEXYPHENIDYL HYDROCHLORIDE ) TABLET [NATCO PHARMA LIMITED-PHARMA DIVISION]	1
TRIHEXYPHENIDYL	ACTIVE MOIETY	6RC5V8B7PO	TRIHEXYPHENIDYL HYDROCHLORIDE (TRIHEXYPHENIDYL HYDROCHLORIDE ) TABLET [NATCO PHARMA LIMITED-PHARMA DIVISION]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRIHEXYPHENIDYL HYDROCHLORIDE (TRIHEXYPHENIDYL HYDROCHLORIDE ) TABLET [NATCO PHARMA LIMITED-PHARMA DIVISION]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRIHEXYPHENIDYL HYDROCHLORIDE (TRIHEXYPHENIDYL HYDROCHLORIDE ) TABLET [NATCO PHARMA LIMITED-PHARMA DIVISION]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRIHEXYPHENIDYL HYDROCHLORIDE (TRIHEXYPHENIDYL HYDROCHLORIDE ) TABLET [NATCO PHARMA LIMITED-PHARMA DIVISION]	1

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trihexyphenidyl Hydrochloride	TRIHEXYPHENIDYL HYDROCHLORIDE	Bionpharma Inc.	4d4d473e-4f84-43e7-bb17-49e8dc1e97fd	2025-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091630 application number: ANDA091630
Trihexyphenidyl Hydrochloride	TRIHEXYPHENIDYL HYDROCHLORIDE	Natco Pharma Limited	b7e4200c-feff-4537-aad1-cf9989fd8c14	2019-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091630 application number: ANDA091630 ndc (product): 63850-0021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
AO61G82577	TRIHEXYPHENIDYL HYDROCHLORIDE	52-49-3	TRIHEXYPHENIDYL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
905269	trihexyphenidyl HCl 2 MG Oral Tablet	PSN	b7e4200c-feff-4537-aad1-cf9989fd8c14	2
905283	trihexyphenidyl HCl 5 MG Oral Tablet	PSN	b7e4200c-feff-4537-aad1-cf9989fd8c14	2
905269	trihexyphenidyl hydrochloride 2 MG Oral Tablet	SCD	b7e4200c-feff-4537-aad1-cf9989fd8c14	2
905283	trihexyphenidyl hydrochloride 5 MG Oral Tablet	SCD	b7e4200c-feff-4537-aad1-cf9989fd8c14	2

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRIHEXYPHENIDYL HYDROCHLORIDE TABLETS, USP	Natco Pharma Limited \| Natco Pharma Limited-Pharma Division	2019-10-25	Human Prescription Drug Label	2