Haloperidol
- Product NDC
- 68084-249
- 11-digit product format
- 680840249
- Labeler code
- 68084
- Product ID
- 68084-249_37b3725e-fe41-d384-e063-6294a90a61da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Haloperidol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA077580
- Marketing category
- ANDA
- Marketing start
- 2008-03-03
- Substance
- HALOPERIDOL
- Active strength
- 10 mg/1
- Pharmacologic classes
- Typical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077580-001 | HALOPERIDOL | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 2023-01-17 | |
| A077580-002 | HALOPERIDOL | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 2023-01-17 | |
| A077580-003 | HALOPERIDOL | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 2007-11-29 | |
| A077580-004 | HALOPERIDOL | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 2007-11-29 | |
| A077580-005 | HALOPERIDOL | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 2007-11-29 | |
| A077580-006 | HALOPERIDOL | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 2023-01-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077580-001 | AB |
| A077580-002 | AB |
| A077580-003 | AB |
| A077580-004 | AB |
| A077580-005 | AB |
| A077580-006 | AB |
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 | A077580-001 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 2023-01-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077580-002 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 2023-01-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077580-003 | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 2007-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077580-004 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 2007-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077580-005 | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 2007-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077580-006 | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 2023-01-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077580-001 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 2023-01-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077580-002 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 2023-01-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077580-003 | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 2007-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077580-004 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 2007-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077580-005 | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 2007-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077580-006 | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 2023-01-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077580-001 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 2023-01-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077580-002 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 2023-01-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077580-003 | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 2007-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077580-004 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 2007-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077580-005 | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 2007-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077580-006 | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 2023-01-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077580-001 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 2023-01-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077580-002 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 2023-01-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077580-003 | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 2007-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077580-004 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 2007-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077580-005 | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 2007-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077580-006 | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 2023-01-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077580-001 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 2023-01-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077580-002 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 2023-01-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077580-003 | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 2007-11-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077580-004 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 2007-11-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077580-005 | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 2007-11-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077580-006 | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 2023-01-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077580-001 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 2023-01-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077580-002 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 2023-01-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077580-003 | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 2007-11-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077580-004 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 2007-11-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077580-005 | HALOPERIDOL | 20MG | TABLET / ORAL | AB | 2007-11-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077580-006 | HALOPERIDOL | 2MG | TABLET / ORAL | AB | 2023-01-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077580-001 | HALOPERIDOL | 0.5MG | TABLET / ORAL | AB | 2023-01-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077580-002 | HALOPERIDOL | 1MG | TABLET / ORAL | AB | 2023-01-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077580-003 | HALOPERIDOL | 5MG | TABLET / ORAL | AB | 2007-11-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077580-004 | HALOPERIDOL | 10MG | TABLET / ORAL | AB | 2007-11-29 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077580-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077580-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077580-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077580-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077580-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077580-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077580-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077580-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077580-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077580-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077580-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077580-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077580-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077580-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077580-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077580-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077580-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077580-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077580-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077580-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077580-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077580-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077580-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077580-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077580-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077580-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077580-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077580-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077580-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077580-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077580-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077580-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077580-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077580-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077580-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077580-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077580-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077580-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077580-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077580-004 | AB | 1 | 2680178bc6a6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Haloperidol
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HALOPERIDOL | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| J6292F8L3D | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0ac0cc44-3924-447d-9051-f84c44312380 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d599bae4-cb25-0798-7468-31aa188fb750 | Product name | 7 | 20260304 |
| 6aae29ef-bf3c-3ebb-3bf1-10ee5424a22e | Product name | 2 | 20250114 |
| af58e43a-5792-c2c1-8e57-a2454df1f2c0 | Product name | 3 | 20240202 |
| ce329990-eb12-45a5-87d5-ce5ef054ca71 | Product name | 2 | 20190930 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68084-249-01 | Haloperidol | 100 in 1 BOX, UNIT-DOSE | TABLET | 100 | 11 | |
| 68084-249-11 | Haloperidol | 1 in 1 BLISTER PACK | TABLET | 1 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68084-249-01 | EA - Each | 68084-249 | 24b1899c-01b2-41ce-b19e-ee70fb98c4a6 | 1 | 2012-07-24 |
| 68084-249-11 | EA - Each | 68084-249 | bc325c60-cb8d-4238-95fe-c9c14b4b016c | 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 |
|---|---|---|---|---|---|---|
| Haloperidol | HALOPERIDOL | REMEDYREPACK INC. | 746f3ab9-9e6e-4ce8-9384-0c7a57de8007 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 077580 ANDA077580 |
| Haloperidol | HALOPERIDOL | Unit Dose Solutions, Inc. | 54ee5fa9-e346-a1d0-e063-6294a90aef83 | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | 077580 ANDA077580 |
| Haloperidol | HALOPERIDOL | Safecor Health, LLC | 9be08519-b3b5-4b9d-ae4c-bb7e68f19ede | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | 077580 ANDA077580 |
| Haloperidol | HALOPERIDOL | Cardinal Health 107, LLC | eaabdc53-366f-4dc2-b9c7-0d70f1bbb6f9 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | 077580 ANDA077580 |
| Haloperidol | HALOPERIDOL | Coupler LLC | 26aa869a-25e8-0dd5-e063-6394a90a0aba | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | 077580 ANDA077580 |
| Haloperidol | HALOPERIDOL | Coupler LLC | 509e5424-1323-c841-e063-6294a90a2714 | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | 077580 ANDA077580 |
| Haloperidol | HALOPERIDOL | Major Pharmaceuticals | e07f02d4-2768-4978-97ee-23ac52d0b846 | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | 077580 ANDA077580 |
| Haloperidol | HALOPERIDOL | REMEDYREPACK INC. | 1e396020-899d-4f51-b71a-4982c503ca4f | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | 077580 ANDA077580 |
| Haloperidol | HALOPERIDOL | REMEDYREPACK INC. | 58fa9328-b1c7-407c-b215-9887db90cb94 | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | 077580 ANDA077580 |
| Haloperidol | HALOPERIDOL | American Health Packaging | 0ac0cc44-3924-447d-9051-f84c44312380 | 2025-06-16 | Boxed warning, Warnings, Adverse reactions | 077580 ANDA077580 68084-249 |
| Haloperidol | HALOPERIDOL | American Health Packaging | d62617da-c8ad-45da-8915-c59edc5558a5 | 2025-06-16 | Boxed warning, Warnings, Adverse reactions | 077580 ANDA077580 |
| Haloperidol | HALOPERIDOL | Coupler LLC | 315899f3-d510-10b0-e063-6294a90a2f3e | 2025-03-27 | Boxed warning, Warnings, Adverse reactions | 077580 ANDA077580 |
| Haloperidol | HALOPERIDOL | Zydus Lifesciences Limited | 509d0eb2-b930-4836-9669-dbebf0ac4076 | 2024-11-30 | 077580 ANDA077580 | |
| Haloperidol | HALOPERIDOL | Zydus Pharmaceuticals USA Inc. | 54502f78-7244-454a-9171-4e73127f1456 | 2024-11-14 | Boxed warning, Warnings, Adverse reactions | 077580 ANDA077580 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314035 | haloperidol 10 MG Oral Tablet | PSN | 0ac0cc44-3924-447d-9051-f84c44312380 | 11 |
| 197754 | haloperidol 20 MG Oral Tablet | PSN | 0ac0cc44-3924-447d-9051-f84c44312380 | 11 |
| 314035 | haloperidol 10 MG Oral Tablet | SCD | 0ac0cc44-3924-447d-9051-f84c44312380 | 11 |
| 197754 | haloperidol 20 MG Oral Tablet | SCD | 0ac0cc44-3924-447d-9051-f84c44312380 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68084-249-01 | 68084024901 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-249-01) / 1 TABLET in 1 BLISTER PACK (68084-249-11) | 100 blister pack | 2008-03-03 | 0000-00-00 | No | No | Current |
| 68084-249-11 | 68084024911 | 1 in 1 BLISTER PACK | Historical |