Thioridazine Hydrochloride
- Product NDC
- 0378-0614
- 11-digit product format
- 003780614
- Labeler code
- 0378
- Product ID
- 0378-0614_6437f615-1e2b-4d0a-ba83-a0c14391693d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- thioridazine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA088004
- Marketing category
- ANDA
- Marketing start
- 1983-03-15
- Substance
- THIORIDAZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A088004-001 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | RS | 1983-11-18 | |
| A088004-002 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1983-03-15 | ||
| A088004-003 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1983-03-15 | ||
| A088004-004 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1983-03-15 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A088004-001 | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | RS | 1983-11-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A088004-002 | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1983-03-15 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A088004-003 | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1983-03-15 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A088004-004 | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1983-03-15 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A088004-001 | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | RS | 1983-11-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A088004-002 | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1983-03-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A088004-003 | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1983-03-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A088004-004 | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1983-03-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A088004-001 | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | RS | 1983-11-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A088004-002 | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1983-03-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A088004-003 | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1983-03-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A088004-004 | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1983-03-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088004-001 | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | RS | 1983-11-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088004-002 | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1983-03-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088004-003 | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1983-03-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088004-004 | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1983-03-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A088004-001 | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | RS | 1983-11-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A088004-002 | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1983-03-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A088004-003 | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1983-03-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A088004-004 | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1983-03-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088004-001 | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | RS | 1983-11-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088004-002 | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1983-03-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088004-003 | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1983-03-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088004-004 | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1983-03-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088004-001 | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | RS | 1983-11-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088004-002 | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1983-03-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088004-003 | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1983-03-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088004-004 | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1983-03-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088004-001 | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | RS | 1983-11-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088004-002 | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1983-03-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088004-003 | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1983-03-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088004-004 | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1983-03-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088004-001 | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | RS | 1983-11-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088004-002 | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1983-03-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088004-003 | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1983-03-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088004-004 | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1983-03-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088004-001 | THIORIDAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | RS | 1983-11-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088004-002 | THIORIDAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1983-03-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088004-003 | THIORIDAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | 1983-03-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088004-004 | THIORIDAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | 1983-03-15 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2020-12-22 03:56 UTC | 2020-12 | A088004-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A088004-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A088004-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A088004-004 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A088004-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A088004-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A088004-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A088004-004 | AB | 1 | c0c555d07b60… |
| 2019-09-15 20:21 UTC | 2019-09 | A088004-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A088004-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A088004-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A088004-004 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A088004-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A088004-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A088004-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A088004-004 | AB | 1 | ea99ee380514… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Thioridazine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| THIORIDAZINE HYDROCHLORIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4WCI67NK8M | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 56b3f4c2-52af-4947-b225-6808ae9f26f5 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 92b3bc4b-cbea-b9aa-f31b-a4133eb6e99b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0378-0614-01 | Thioridazine Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-0614-01 | EA - Each | 0378-0614 | bd41d3d2-41e4-45cd-aab4-ab7139b82e32 | 1 | 2012-07-24 |
| 0378-0614-10 | EA - Each | 0378-0614 | bd1421fe-551f-4f4c-99fe-54b9d2ee41c3 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Thioridazine Hydrochloride | THIORIDAZINE HYDROCHLORIDE | Safecor Health LLC | 1fd16a99-e856-4a37-9dae-c443714fac14 | 2026-03-02 | Boxed warning, Warnings, Adverse reactions | 088004 ANDA088004 |
| Thioridazine Hydrochloride | THIORIDAZINE HYDROCHLORIDE | Mylan Institutional Inc. | 52fea941-0b47-41c1-b00d-f88150e8ab93 | 2025-11-11 | Boxed warning, Warnings, Adverse reactions | 088004 ANDA088004 |
| Thioridazine Hydrochloride | THIORIDAZINE HYDROCHLORIDE | Mylan Pharmaceuticals Inc. | 56b3f4c2-52af-4947-b225-6808ae9f26f5 | 2025-01-15 | Boxed warning, Warnings, Adverse reactions | 088004 ANDA088004 0378-0614 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313354 | thioridazine HCl 10 MG Oral Tablet | PSN | 56b3f4c2-52af-4947-b225-6808ae9f26f5 | 15 |
| 313354 | thioridazine HCl 10 MG Oral Tablet | PSN | 52fea941-0b47-41c1-b00d-f88150e8ab93 | 15 |
| 198270 | thioridazine HCl 100 MG Oral Tablet | PSN | 52fea941-0b47-41c1-b00d-f88150e8ab93 | 15 |
| 198270 | thioridazine HCl 100 MG Oral Tablet | PSN | 56b3f4c2-52af-4947-b225-6808ae9f26f5 | 15 |
| 198274 | thioridazine HCl 25 MG Oral Tablet | PSN | 56b3f4c2-52af-4947-b225-6808ae9f26f5 | 15 |
| 198274 | thioridazine HCl 25 MG Oral Tablet | PSN | 52fea941-0b47-41c1-b00d-f88150e8ab93 | 15 |
| 198275 | thioridazine HCl 50 MG Oral Tablet | PSN | 56b3f4c2-52af-4947-b225-6808ae9f26f5 | 15 |
| 198275 | thioridazine HCl 50 MG Oral Tablet | PSN | 52fea941-0b47-41c1-b00d-f88150e8ab93 | 15 |
| 313354 | thioridazine 10 MG Oral Tablet | SCD | 52fea941-0b47-41c1-b00d-f88150e8ab93 | 15 |
| 313354 | thioridazine 10 MG Oral Tablet | SCD | 56b3f4c2-52af-4947-b225-6808ae9f26f5 | 15 |
| 198270 | thioridazine 100 MG Oral Tablet | SCD | 56b3f4c2-52af-4947-b225-6808ae9f26f5 | 15 |
| 198270 | thioridazine 100 MG Oral Tablet | SCD | 52fea941-0b47-41c1-b00d-f88150e8ab93 | 15 |
| 198274 | thioridazine 25 MG Oral Tablet | SCD | 56b3f4c2-52af-4947-b225-6808ae9f26f5 | 15 |
| 198274 | thioridazine 25 MG Oral Tablet | SCD | 52fea941-0b47-41c1-b00d-f88150e8ab93 | 15 |
| 198275 | thioridazine 50 MG Oral Tablet | SCD | 56b3f4c2-52af-4947-b225-6808ae9f26f5 | 15 |
| 198275 | thioridazine 50 MG Oral Tablet | SCD | 52fea941-0b47-41c1-b00d-f88150e8ab93 | 15 |
| 198274 | thioridazine (as thioridazine hydrochloride) 25 MG Oral Tablet | SY | 56b3f4c2-52af-4947-b225-6808ae9f26f5 | 15 |
| 198274 | thioridazine (as thioridazine hydrochloride) 25 MG Oral Tablet | SY | 52fea941-0b47-41c1-b00d-f88150e8ab93 | 15 |
| 198275 | thioridazine (as thioridazine hydrochloride) 50 MG Oral Tablet | SY | 52fea941-0b47-41c1-b00d-f88150e8ab93 | 15 |
| 198275 | thioridazine (as thioridazine hydrochloride) 50 MG Oral Tablet | SY | 56b3f4c2-52af-4947-b225-6808ae9f26f5 | 15 |
| 313354 | thioridazine HCl 10 MG Oral Tablet | PSN | 1fd16a99-e856-4a37-9dae-c443714fac14 | 2 |
| 198270 | thioridazine HCl 100 MG Oral Tablet | PSN | 1fd16a99-e856-4a37-9dae-c443714fac14 | 2 |
| 198274 | thioridazine HCl 25 MG Oral Tablet | PSN | 1fd16a99-e856-4a37-9dae-c443714fac14 | 2 |
| 198275 | thioridazine HCl 50 MG Oral Tablet | PSN | 1fd16a99-e856-4a37-9dae-c443714fac14 | 2 |
| 313354 | thioridazine 10 MG Oral Tablet | SCD | 1fd16a99-e856-4a37-9dae-c443714fac14 | 2 |
| 198270 | thioridazine 100 MG Oral Tablet | SCD | 1fd16a99-e856-4a37-9dae-c443714fac14 | 2 |
| 198274 | thioridazine 25 MG Oral Tablet | SCD | 1fd16a99-e856-4a37-9dae-c443714fac14 | 2 |
| 198275 | thioridazine 50 MG Oral Tablet | SCD | 1fd16a99-e856-4a37-9dae-c443714fac14 | 2 |
| 198274 | thioridazine (as thioridazine hydrochloride) 25 MG Oral Tablet | SY | 1fd16a99-e856-4a37-9dae-c443714fac14 | 2 |
| 198275 | thioridazine (as thioridazine hydrochloride) 50 MG Oral Tablet | SY | 1fd16a99-e856-4a37-9dae-c443714fac14 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0378-0614-01 | 00378061401 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0614-01) | 1983-03-15 | 0000-00-00 | No | No | Current |