Trihexyphenidyl Hydrochloride

Product NDC: 69452-242
Requested package NDC: 69452-242-20
11-digit product format: 694520242
Labeler code: 69452
Product ID: 69452-242_4d4d473e-4f84-43e7-bb17-49e8dc1e97fd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trihexyphenidyl Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bionpharma Inc.
Application: ANDA091630
Marketing category: ANDA
Marketing start: 2018-12-15
Marketing end: 0000-00-00
Substance: TRIHEXYPHENIDYL HYDROCHLORIDE
Active strength: 5 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69452-242	69452-242-20	D	Discontinued by firm		2026-08-11

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…`

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
69452-242-20	Trihexyphenidyl Hydrochloride	100 in 1 BOTTLE	TABLET	100		3
69452-242-32	Trihexyphenidyl Hydrochloride	1000 in 1 BOTTLE	TABLET	1000		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69452-242-20	EA - Each	69452-242	a321e0d9-dc55-41f3-af36-b24ede7683ef	1	2019-01-24
69452-242-32	EA - Each	69452-242	0dd6c207-b72a-4be5-84b0-2c3c5d13aa39	1	2019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-242	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [BIONPHARMA INC.]	2	Legacy NDC, 2 package rows	20250114_4d4d473e-4f84-43e7-bb17-49e8dc1e97fd.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 ndc (package): 69452-242-20 ndc (product): 69452-242 ndc11 (package): 69452024220
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

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	4d4d473e-4f84-43e7-bb17-49e8dc1e97fd	3
905283	trihexyphenidyl HCl 5 MG Oral Tablet	PSN	4d4d473e-4f84-43e7-bb17-49e8dc1e97fd	3
905269	trihexyphenidyl hydrochloride 2 MG Oral Tablet	SCD	4d4d473e-4f84-43e7-bb17-49e8dc1e97fd	3
905283	trihexyphenidyl hydrochloride 5 MG Oral Tablet	SCD	4d4d473e-4f84-43e7-bb17-49e8dc1e97fd	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69452-242-20	69452024220	100 TABLET in 1 BOTTLE (69452-242-20)	100 tablet	2018-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trihexyphenidyl Hydrochloride - Bionpharma Inc. \| NATCO PHARMA LIMITED \| Natco Pharma Limited-Pharma Division	Bionpharma Inc. \| NATCO PHARMA LIMITED \| Natco Pharma Limited-Pharma Division	2025-07-02	HUMAN PRESCRIPTION DRUG LABEL	3
Trihexyphenidyl Hydrochloride - REMEDYREPACK INC.	REMEDYREPACK INC.	2022-04-19	HUMAN PRESCRIPTION DRUG LABEL	3