Trihexyphenidyl Hydrochloride

Product NDC: 61748-054
11-digit product format: 617480054
Labeler code: 61748
Product ID: 61748-054_3a17b358-46b6-4e74-9788-ccb8acf9ca8f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trihexyphenidyl Hydrochloride
Dosage form: SYRUP
Route: ORAL
Labeler: Akorn
Application: ANDA040251
Marketing category: ANDA
Marketing start: 2001-03-01
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
A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA		1999-09-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040251-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`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	A040251-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040251-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040251-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040251-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040251-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040251-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040251-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040251-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040251-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040251-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040251-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040251-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040251-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040251-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040251-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040251-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040251-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040251-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040251-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040251-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040251-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040251-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040251-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040251-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040251-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040251-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040251-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040251-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040251-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040251-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040251-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040251-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040251-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040251-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040251-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040251-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040251-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040251-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040251-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040251-001	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
294cd88d-d9e8-4938-b4be-c3adc4a35de0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
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
61748-054-16	Trihexyphenidyl Hydrochloride	473 mL in 1 BOTTLE, PLASTIC	SYRUP	473		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61748-054-16	ML - Milliliter	61748-054	45b49142-a3d9-4c34-a318-f7d1fa63ddaa	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRIHEXYPHENIDYL HYDROCHLORIDE	ACTIVE INGREDIENT	AO61G82577	TRIHEXYPHENIDYL HYDROCHLORIDE SYRUP [VERSAPHARM INCORPORATED]	5
TRIHEXYPHENIDYL	ACTIVE MOIETY	6RC5V8B7PO	TRIHEXYPHENIDYL HYDROCHLORIDE SYRUP [VERSAPHARM INCORPORATED]	5
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	TRIHEXYPHENIDYL HYDROCHLORIDE SYRUP [VERSAPHARM INCORPORATED]	5
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	TRIHEXYPHENIDYL HYDROCHLORIDE SYRUP [VERSAPHARM INCORPORATED]	5
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	TRIHEXYPHENIDYL HYDROCHLORIDE SYRUP [VERSAPHARM INCORPORATED]	5
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	TRIHEXYPHENIDYL HYDROCHLORIDE SYRUP [VERSAPHARM INCORPORATED]	5
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	TRIHEXYPHENIDYL HYDROCHLORIDE SYRUP [VERSAPHARM INCORPORATED]	5
SORBITOL	INACTIVE INGREDIENT	506T60A25R	TRIHEXYPHENIDYL HYDROCHLORIDE SYRUP [VERSAPHARM INCORPORATED]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	TRIHEXYPHENIDYL HYDROCHLORIDE SYRUP [VERSAPHARM INCORPORATED]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61748-054	TRIHEXYPHENIDYL HYDROCHLORIDE SYRUP [AKORN]	9	Current NDC, Legacy NDC, 1 package rows	20220623_294cd88d-d9e8-4938-b4be-c3adc4a35de0.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	Chartwell RX, LLC	e8e2ac3b-80dc-4449-9365-2586d6d57e10	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040251 application number: ANDA040251
Trihexyphenidyl Hydrochloride	TRIHEXYPHENIDYL HYDROCHLORIDE	Akorn	294cd88d-d9e8-4938-b4be-c3adc4a35de0	2022-06-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040251 application number: ANDA040251 ndc (product): 61748-054

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	294cd88d-d9e8-4938-b4be-c3adc4a35de0	9
905273	trihexyphenidyl hydrochloride 0.4 MG/ML Oral Solution	SCD	294cd88d-d9e8-4938-b4be-c3adc4a35de0	9
905273	trihexyphenidyl HCl 2 MG per 5 ML Oral Solution	SY	294cd88d-d9e8-4938-b4be-c3adc4a35de0	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61748-054-16	61748005416	473 mL in 1 BOTTLE, PLASTIC (61748-054-16)	473 ml	2001-03-01	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.	2023-03-23	HUMAN PRESCRIPTION DRUG LABEL	2
Trihexyphenidyl Hydrochloride Oral Solution, USP 2 mg per 5 mL	Akorn \| Akorn Operating Company LLC \| Mikart, LLC	2022-06-21	HUMAN PRESCRIPTION DRUG LABEL	9