Haloperidol
- Product NDC
- 50268-391
- 11-digit product format
- 502680391
- Labeler code
- 50268
- Product ID
- 50268-391_be35f476-b385-2e22-e053-2a95a90a5199
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Haloperidol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA077580
- Marketing category
- ANDA
- Marketing start
- 2021-03-23
- Marketing end
- 0000-00-00
- Substance
- HALOPERIDOL
- Active strength
- 5 mg/1
- Pharmacologic classes
- Typical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 | 50268-391 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 50268-391 | 50268-391-15 | D | Discontinued by firm | 2026-08-03 |
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 | 50268-391-15 | 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 | 50268-391-15 | 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 | 50268-391-15 | 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 | 50268-391-15 | 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 | 50268-391-15 | 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 | 50268-391-15 | 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 | 50268-391-15 | 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 | 50268-391-15 | 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 | 50268-391-15 | 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 | 50268-391-15 | 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 | 50268-391-15 | 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 | 50268-391-15 | 557ba5c1ecfa… | 9c80585c8c6e… |
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… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50268-391-11 | EA - Each | 50268-391 | 977c94b9-568c-4ee3-8202-0788fcde8a37 | 1 | 2021-04-08 |
| 50268-391-15 | EA - Each | 50268-391 | 2d69721c-8d3e-4a44-9bc6-8aada292bea1 | 1 | 2021-04-08 |
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 |
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50268-391-15 | 50268039115 | 50 BLISTER PACK in 1 BOX (50268-391-15) > 1 TABLET in 1 BLISTER PACK (50268-391-11) | 50 blister pack | 2021-03-23 | 0000-00-00 | No | No | Current |