Trihexyphenidyl Hydrochloride

Product NDC: 70518-2880
11-digit product format: 705182880
Labeler code: 70518
Product ID: 70518-2880_dd019ac9-1f94-767f-e053-2a95a90ab209
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trihexyphenidyl Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA091630
Marketing category: ANDA
Marketing start: 2020-09-14
Marketing end: 0000-00-00
Substance: TRIHEXYPHENIDYL HYDROCHLORIDE
Active strength: 5 mg/1
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70518-2880		D	Discontinued by firm	2026-10-15
excluded package	package	70518-2880	70518-2880-0	D	Discontinued by firm	2026-10-15
excluded package	package	70518-2880	70518-2880-2	D	Discontinued by firm	2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-2880-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-2880-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-2880-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-2880-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-2880-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-2880-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-2880-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-2880-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-2880-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-2880-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-2880-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-2880-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-2880-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-2880-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-2880-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-2880-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-2880-0	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-2880-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-2880-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-2880-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-2880-0	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-2880-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-2880-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-2880-2	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 88 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
2026-10-15 13:18:30	2026-09	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091630-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091630-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091630-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091630-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091630-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091630-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091630-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091630-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091630-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091630-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091630-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091630-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091630-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091630-002	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091630-001	AA	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091630-002	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091630-001	AA	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A091630-002	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091630-001	AA	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A091630-002	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091630-001	AA	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091630-002	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091630-001	AA	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091630-002	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091630-001	AA	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091630-002	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091630-001	AA	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091630-002	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091630-001	AA	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A091630-002	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091630-001	AA	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A091630-002	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091630-001	AA	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091630-002	AA	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2880-0	70518288000	100 POUCH in 1 BOX (70518-2880-0) > 1 TABLET in 1 POUCH (70518-2880-1)	100 pouch	2020-09-14	0000-00-00	No	No	Current
70518-2880-2	70518288002	30 TABLET in 1 BLISTER PACK (70518-2880-2)	30 tablet	2021-04-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trihexyphenidyl Hydrochloride - REMEDYREPACK INC.	REMEDYREPACK INC.	2022-04-19	HUMAN PRESCRIPTION DRUG LABEL	3