TRIHEXYPHENIDYL HYDROCHLORIDE
- Product NDC
- 50090-5205
- 11-digit product format
- 500905205
- Labeler code
- 50090
- Product ID
- 50090-5205_6c1f4c84-4d1a-4ea2-ba53-abb4247405d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRIHEXYPHENIDYL HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA040254
- Marketing category
- ANDA
- Marketing start
- 2019-01-28
- Marketing end
- 0000-00-00
- Substance
- TRIHEXYPHENIDYL HYDROCHLORIDE
- Active strength
- 5 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 50090-5205 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 50090-5205 | 50090-5205-0 | D | Discontinued by firm | 2026-08-11 |
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.
| 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 | 50090-5205-0 | 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 | 50090-5205-0 | 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 | 50090-5205-0 | 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 | 50090-5205-0 | 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 | 50090-5205-0 | 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 | 50090-5205-0 | 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 | 50090-5205-0 | 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 | 50090-5205-0 | 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 | 50090-5205-0 | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| 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#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | 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#
| 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… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-5205-0 | 2023-02-07 | C162847 | 48780-1 | f386c64a-4360-0266-e053-dadaa90a7c1a | Novitium Pharma LLC. TRIHEXYPHENIDYL HYDROCHLORIDE Tablets, USP 2 mg and 5 mg Rx Only |
| 50090-5205-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-4360-0266-e053-dadaa90a7c1a | Novitium Pharma LLC. TRIHEXYPHENIDYL HYDROCHLORIDE Tablets, USP 2 mg and 5 mg Rx Only |
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.
| 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 | 040254 ANDA040254 |
| TRIHEXYPHENIDYL HYDROCHLORIDE | TRIHEXYPHENIDYL HYDROCHLORIDE | REMEDYREPACK INC. | b60ef86c-b8b6-4530-baaf-d4671ce961af | 2026-07-23 | Warnings, Adverse reactions | 040254 ANDA040254 |
| TRIHEXYPHENIDYL HYDROCHLORIDE | TRIHEXYPHENIDYL HYDROCHLORIDE | Golden State Medical Supply Inc. | 9040cb3b-13d2-e46d-e053-2a95a90ae9e6 | 2023-09-26 | Warnings, Adverse reactions | 040254 ANDA040254 |
| TRIHEXYPHENIDYL HYDROCHLORIDE | TRIHEXYPHENIDYL HYDROCHLORIDE | Novitium Pharma LLC | 83608c13-509d-448b-8559-5f5e8a9a0d75 | 2019-01-28 | Warnings, Adverse reactions | 040254 ANDA040254 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-5205-0 | 50090520500 | 1 BOX, UNIT-DOSE in 1 BLISTER PACK (50090-5205-0) > 32 TABLET in 1 BOX, UNIT-DOSE | 2020-10-05 | 0000-00-00 | No | No | Current |