Haloperidol
- Product NDC
- 58657-903
- 11-digit product format
- 586570903
- Labeler code
- 58657
- Product ID
- 58657-903_38c21c0c-f6b3-adda-e063-6294a90a0ffd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Haloperidol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Method Pharmaceuticals, LLC
- Application
- ANDA071173
- Marketing category
- ANDA
- Marketing start
- 2025-06-05
- Substance
- HALOPERIDOL
- Active strength
- 5 mg/1
- Pharmacologic classes
- Typical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Haloperidol
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HALOPERIDOL | 5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | J6292F8L3D |
| Rxcui | 197754, 310670, 310671, 310672, 314034, 314035 |
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 |
|---|---|---|---|---|---|---|
| 58657-903-01 | Haloperidol | 100 in 1 CARTON | TABLET | 100 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58657-903-01 | EA - Each | 58657-903 | f226c59f-1bf4-483a-b3d4-4067013086fb | 1 | 2025-09-12 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310670 | haloperidol 0.5 MG Oral Tablet | PSN | 87f8773b-bf89-4f7e-bff4-8cad117d5776 | 7 |
| 310671 | haloperidol 1 MG Oral Tablet | PSN | 87f8773b-bf89-4f7e-bff4-8cad117d5776 | 7 |
| 314035 | haloperidol 10 MG Oral Tablet | PSN | 87f8773b-bf89-4f7e-bff4-8cad117d5776 | 7 |
| 314034 | haloperidol 2 MG Oral Tablet | PSN | 87f8773b-bf89-4f7e-bff4-8cad117d5776 | 7 |
| 197754 | haloperidol 20 MG Oral Tablet | PSN | 87f8773b-bf89-4f7e-bff4-8cad117d5776 | 7 |
| 310672 | haloperidol 5 MG Oral Tablet | PSN | 87f8773b-bf89-4f7e-bff4-8cad117d5776 | 7 |
| 310670 | haloperidol 0.5 MG Oral Tablet | SCD | 87f8773b-bf89-4f7e-bff4-8cad117d5776 | 7 |
| 310671 | haloperidol 1 MG Oral Tablet | SCD | 87f8773b-bf89-4f7e-bff4-8cad117d5776 | 7 |
| 314035 | haloperidol 10 MG Oral Tablet | SCD | 87f8773b-bf89-4f7e-bff4-8cad117d5776 | 7 |
| 314034 | haloperidol 2 MG Oral Tablet | SCD | 87f8773b-bf89-4f7e-bff4-8cad117d5776 | 7 |
| 197754 | haloperidol 20 MG Oral Tablet | SCD | 87f8773b-bf89-4f7e-bff4-8cad117d5776 | 7 |
| 310672 | haloperidol 5 MG Oral Tablet | SCD | 87f8773b-bf89-4f7e-bff4-8cad117d5776 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 58657-903-01 | 58657090301 | 100 TABLET in 1 CARTON (58657-903-01) | 100 tablet | 2025-06-05 | No | No | Current |