trihexyphenidyl hydrochloride

Product NDC: 46672-635
11-digit product format: 466720635
Labeler code: 46672
Product ID: 46672-635_910438b7-4a8f-a7f5-e053-2995a90a88de
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: trihexyphenidyl hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Mikart, LLC
Application: ANDA040251
Marketing category: ANDA
Marketing start: 1999-10-04
Marketing end: 0000-00-00
Substance: TRIHEXYPHENIDYL HYDROCHLORIDE
Active strength: 2 mg/5mL
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRIHEXYPHENIDYL HYDROCHLORIDE	ACTIVE INGREDIENT	AO61G82577	TRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [MIKART, INC.]	1
TRIHEXYPHENIDYL	ACTIVE MOIETY	6RC5V8B7PO	TRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [MIKART, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	TRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [MIKART, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	TRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [MIKART, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	TRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [MIKART, INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	TRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [MIKART, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TRIHEXYPHENIDYL HYDROCHLORIDE SOLUTION [MIKART, INC.]	1

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
46672-635-16	46672063516	473 mL in 1 BOTTLE, PLASTIC (46672-635-16)	473 ml	2009-10-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
trihexyphenidyl hydrochloride - Mikart, LLC	Mikart, LLC	2019-08-26	HUMAN PRESCRIPTION DRUG LABEL	2