Trihexyphenidyl Hydrochloride

Product NDC: 0591-5337
11-digit product format: 005915337
Labeler code: 0591
Product ID: 0591-5337_0b42f7c5-1597-46fd-bc35-5f9286d27877
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trihexyphenidyl Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA084364
Marketing category: ANDA
Marketing start: 1987-11-01
Substance: TRIHEXYPHENIDYL HYDROCHLORIDE
Active strength: 5 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
unfinished product	product	0591-5337		UNFINISHED	Active or certified unfinished drug listing	2026-08-12
unfinished package	package	0591-5337	0591-5337-00	UNFINISHED	Active or certified unfinished drug listing	2026-08-12
unfinished package	package	0591-5337	0591-5337-77	UNFINISHED	Active or certified unfinished drug listing	2026-08-12

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 · 53 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 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	0591-5337-77	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	0591-5337-00	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	0591-5337-77	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	0591-5337-00	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	0591-5337-77	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	0591-5337-00	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	0591-5337-77	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	0591-5337-00	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	0591-5337-77	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	0591-5337-00	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	0591-5337-77	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	0591-5337-00	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	0591-5337-77	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	0591-5337-00	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	0591-5337-77	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	0591-5337-00	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	0591-5337-77	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	0591-5337-00	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	0591-5337-77	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	0591-5337-00	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	0591-5337-77	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	0591-5337-00	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	0591-5337-00	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	0591-5337-00	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	0591-5337-00	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	0591-5337-00	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	0591-5337-00	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	0591-5337-00	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	0591-5337-00	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	0591-5337-00	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	0591-5337-00	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	0591-5337-00	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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
A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A084364-001	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`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	A084364-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084364-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084364-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084364-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084364-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084364-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084364-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084364-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084364-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084364-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084364-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084364-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084364-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084364-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084364-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084364-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084364-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084364-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084364-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084364-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084364-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084364-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084364-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084364-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084364-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084364-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084364-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084364-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084364-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084364-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084364-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084364-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084364-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084364-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084364-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084364-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084364-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084364-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084364-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084364-001	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	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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
905269	Internal RxNorm lookup
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
a44d7803-164d-4a67-9356-581c45de8596	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	Strength	SPL version
0591-5337-01	Trihexyphenidyl Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET	100		10
0591-5337-10	Trihexyphenidyl Hydrochloride	1000 in 1 BOTTLE, PLASTIC	TABLET	1000		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-5337-01	EA - Each	0591-5337	b31deceb-bdbf-4688-b7e3-2e61cb63a8f5	1	2012-07-24
0591-5337-10	EA - Each	0591-5337	a4c91b59-a4e7-440c-badb-b85b28379804	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRIHEXYPHENIDYL HYDROCHLORIDE	ACTIVE INGREDIENT	AO61G82577	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]	5
TRIHEXYPHENIDYL	ACTIVE MOIETY	6RC5V8B7PO	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]	5
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [WATSON LABORATORIES, INC.]	5
TRIHEXYPHENIDYL HYDROCHLORIDE	ACTIVE INGREDIENT	AO61G82577	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TRIHEXYPHENIDYL HYDROCHLORIDE	ACTIVE INGREDIENT	AO61G82577	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
TRIHEXYPHENIDYL	ACTIVE MOIETY	6RC5V8B7PO	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
TRIHEXYPHENIDYL	ACTIVE MOIETY	6RC5V8B7PO	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-5337	TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	10	Current NDC, Legacy NDC, 2 package rows	20250116_a44d7803-164d-4a67-9356-581c45de8596.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trihexyphenidyl Hydrochloride	TRIHEXYPHENIDYL HYDROCHLORIDE	REMEDYREPACK INC.	3e71b957-9495-4583-8f00-99eac715ff85	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084364 application number: ANDA084364
Trihexyphenidyl Hydrochloride	TRIHEXYPHENIDYL HYDROCHLORIDE	REMEDYREPACK INC.	3ed3cdf1-1745-4c6f-bb90-fb7d9471270d	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084364 application number: ANDA084364
Trihexyphenidyl Hydrochloride	TRIHEXYPHENIDYL HYDROCHLORIDE	Actavis Pharma, Inc.	a44d7803-164d-4a67-9356-581c45de8596	2024-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084364 application number: ANDA084364 ndc (product): 0591-5337

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	3ed3cdf1-1745-4c6f-bb90-fb7d9471270d	15
905283	trihexyphenidyl hydrochloride 5 MG Oral Tablet	SCD	3ed3cdf1-1745-4c6f-bb90-fb7d9471270d	15
905283	trihexyphenidyl HCl 5 MG Oral Tablet	PSN	3e71b957-9495-4583-8f00-99eac715ff85	12
905283	trihexyphenidyl hydrochloride 5 MG Oral Tablet	SCD	3e71b957-9495-4583-8f00-99eac715ff85	12
905269	trihexyphenidyl HCl 2 MG Oral Tablet	PSN	a44d7803-164d-4a67-9356-581c45de8596	10
905283	trihexyphenidyl HCl 5 MG Oral Tablet	PSN	a44d7803-164d-4a67-9356-581c45de8596	10
905269	trihexyphenidyl hydrochloride 2 MG Oral Tablet	SCD	a44d7803-164d-4a67-9356-581c45de8596	10
905283	trihexyphenidyl hydrochloride 5 MG Oral Tablet	SCD	a44d7803-164d-4a67-9356-581c45de8596	10
905283	trihexyphenidyl HCl 5 MG Oral Tablet	PSN	b1468533-a9b8-4377-ae6c-5640e73b9e08	1
905283	trihexyphenidyl hydrochloride 5 MG Oral Tablet	SCD	b1468533-a9b8-4377-ae6c-5640e73b9e08	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-5337-00	00591533700	33000 TABLET in 1 BAG (0591-5337-00)	33000 tablet	01-NOV-87				Current
0591-5337-01	00591533701	100 TABLET in 1 BOTTLE, PLASTIC (0591-5337-01)	100 tablet	1987-11-01	0000-00-00	No	No	Current
0591-5337-10	00591533710	1000 TABLET in 1 BOTTLE, PLASTIC (0591-5337-10)	1000 tablet	1987-11-01	0000-00-00	No	No	Current
0591-5337-77	00591533777	40008 TABLET in 1 CONTAINER (0591-5337-77)	40008 tablet	22-JUL-24				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trihexyphenidyl Hydrochloride Tablets, USP Rx only	REMEDYREPACK INC.	2026-07-09	HUMAN PRESCRIPTION DRUG LABEL	13
Trihexyphenidyl Hydrochloride Tablets, USP Rx only	REMEDYREPACK INC.	2026-07-02	HUMAN PRESCRIPTION DRUG LABEL	16
Trihexyphenidyl Hydrochloride Tablets, USP Rx only	Actavis Pharma, Inc.	2024-02-02	HUMAN PRESCRIPTION DRUG LABEL	10
Trihexyphenidyl Hydrochloride Tablets USP Rx only	State of Florida DOH Central Pharmacy	2013-10-01	HUMAN PRESCRIPTION DRUG LABEL	1
Trihexyphenidyl Hydrochloride Tablets USP Rx only	NCS HealthCare of KY, Inc dba Vangard Labs	2010-06-17	HUMAN PRESCRIPTION DRUG LABEL	1