Trihexyphenidyl Hydrochloride

Product NDC: 0121-0658
11-digit product format: 001210658
Labeler code: 0121
Product ID: 0121-0658_e3815d2f-f3ee-4cd6-8a2d-518c74787152
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trihexyphenidyl Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: ANDA040177
Marketing category: ANDA
Marketing start: 1997-05-15
Substance: TRIHEXYPHENIDYL HYDROCHLORIDE
Active strength: 2 mg/5mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A040177-001	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 2 · 41 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	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040177-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	RS	1997-04-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A040177-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040177-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040177-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040177-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040177-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040177-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040177-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040177-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040177-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040177-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040177-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040177-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040177-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040177-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040177-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040177-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040177-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040177-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040177-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040177-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040177-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040177-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040177-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040177-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040177-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040177-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040177-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040177-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040177-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040177-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040177-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040177-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040177-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040177-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040177-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040177-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040177-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040177-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040177-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040177-001	AA	1	`cb3db0bc1861…`

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/5mL

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
905273	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
9036c9f0-6d2d-4d0f-a20e-e36f9be228f7	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	Strength	SPL version
0121-0658-16	Trihexyphenidyl Hydrochloride	473 mL in 1 BOTTLE	SOLUTION	473		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-0658-16	ML - Milliliter	0121-0658	a60e8e66-e78d-44d1-b4ad-3486d25c8655	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Trihexyphenidyl Hydrochloride	ACTIVE INGREDIENT	AO61G82577	TRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
Trihexyphenidyl	ACTIVE MOIETY	6RC5V8B7PO	TRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	TRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	TRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	TRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	TRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	TRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	TRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	TRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-0658	TRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]	8	Current NDC, Legacy NDC, 1 package rows	20241121_9036c9f0-6d2d-4d0f-a20e-e36f9be228f7.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trihexyphenidyl Hydrochloride	TRIHEXYPHENIDYL HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	9036c9f0-6d2d-4d0f-a20e-e36f9be228f7	2024-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040177 application number: ANDA040177 ndc (product): 0121-0658

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
905273	trihexyphenidyl HCl 2 MG in 5 mL Oral Solution	PSN	9036c9f0-6d2d-4d0f-a20e-e36f9be228f7	8
905273	trihexyphenidyl hydrochloride 0.4 MG/ML Oral Solution	SCD	9036c9f0-6d2d-4d0f-a20e-e36f9be228f7	8
905273	trihexyphenidyl HCl 2 MG per 5 ML Oral Solution	SY	9036c9f0-6d2d-4d0f-a20e-e36f9be228f7	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-0658-16	00121065816	473 mL in 1 BOTTLE (0121-0658-16)	473 ml	1997-05-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trihexyphenidyl Hydrochloride Oral Solution USP 2 mg per 5 mL	REMEDYREPACK INC.	2025-07-18	HUMAN PRESCRIPTION DRUG LABEL	9
Trihexyphenidyl Hydrochloride Oral Solution USP 2 mg per 5 mL	PAI Holdings, LLC dba PAI Pharma \| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	2024-11-19	HUMAN PRESCRIPTION DRUG LABEL	8