TRIHEXYPHENIDYL HYDROCHLORIDE

Product NDC: 70518-2409
Requested package NDC: 70518-2409-4
11-digit product format: 705182409
Labeler code: 70518
Product ID: 70518-2409_4a17b684-8b80-215c-e063-6394a90a6e19
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TRIHEXYPHENIDYL HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA040254
Marketing category: ANDA
Marketing start: 2019-11-08
Substance: TRIHEXYPHENIDYL HYDROCHLORIDE
Active strength: 5 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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	70518-2409	70518-2409-4	D	Discontinued by firm		2026-08-03

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
A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA		1998-12-24
A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA		1998-12-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040254-001	AA
A040254-002	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	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`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	A040254-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040254-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040254-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040254-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040254-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040254-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040254-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040254-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040254-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040254-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040254-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040254-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040254-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040254-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040254-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040254-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040254-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040254-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040254-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040254-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040254-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040254-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040254-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040254-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040254-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040254-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040254-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040254-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040254-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040254-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040254-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040254-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040254-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040254-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040254-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040254-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040254-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040254-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040254-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040254-002	AA	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: TRIHEXYPHENIDYL HYDROCHLORIDE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRIHEXYPHENIDYL HYDROCHLORIDE	5 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
c25ea809-5bdf-4917-97f1-610059fbd0b7	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
70518-2409-0	TRIHEXYPHENIDYL HYDROCHLORIDE	100 in 1 BOX	TABLET	100	12
70518-2409-1	TRIHEXYPHENIDYL HYDROCHLORIDE	1 in 1 POUCH	TABLET	1	12
70518-2409-2	TRIHEXYPHENIDYL HYDROCHLORIDE	100 in 1 BOX	TABLET	100	12
70518-2409-3	TRIHEXYPHENIDYL HYDROCHLORIDE	1 in 1 POUCH	TABLET	1	12
70518-2409-4	TRIHEXYPHENIDYL HYDROCHLORIDE	30 in 1 BLISTER PACK	TABLET	30	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-2409	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [REMEDYREPACK INC.]	10	Current NDC, Legacy NDC, 5 package rows	20250521_c25ea809-5bdf-4917-97f1-610059fbd0b7.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	REMEDYREPACK INC.	c25ea809-5bdf-4917-97f1-610059fbd0b7	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040254 application number: ANDA040254 ndc (package): 70518-2409-4 ndc (product): 70518-2409 ndc11 (package): 70518240904
TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	REMEDYREPACK INC.	b60ef86c-b8b6-4530-baaf-d4671ce961af	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040254 application number: ANDA040254
TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	Golden State Medical Supply Inc.	9040cb3b-13d2-e46d-e053-2a95a90ae9e6	2023-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040254 application number: ANDA040254
TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	Novitium Pharma LLC	83608c13-509d-448b-8559-5f5e8a9a0d75	2019-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040254 application number: ANDA040254

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
905283	trihexyphenidyl HCl 5 MG Oral Tablet	PSN	c25ea809-5bdf-4917-97f1-610059fbd0b7	12
905283	trihexyphenidyl hydrochloride 5 MG Oral Tablet	SCD	c25ea809-5bdf-4917-97f1-610059fbd0b7	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2409-4	70518240904	30 TABLET in 1 BLISTER PACK (70518-2409-4)	30 tablet	2021-10-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Novitium Pharma LLC. TRIHEXYPHENIDYL HYDROCHLORIDE Tablets, USP 2 mg and 5 mg Rx Only	REMEDYREPACK INC.	2026-07-23	HUMAN PRESCRIPTION DRUG LABEL	13