Haloperidol
- Product NDC
- 51079-735
- 11-digit product format
- 510790735
- Labeler code
- 51079
- Product ID
- 51079-735_3dd4fea4-d455-5a4d-e063-6394a90ab14c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- haloperidol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Institutional Inc.
- Application
- ANDA070278
- Marketing category
- ANDA
- Marketing start
- 2004-02-15
- Substance
- HALOPERIDOL
- Active strength
- 2 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 | 2 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | J6292F8L3D |
| Rxcui | 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 |
|---|---|---|---|---|---|---|
| 51079-735-01 | Haloperidol | 1 in 1 BLISTER PACK | TABLET | 1 | 18 | |
| 51079-735-20 | Haloperidol | 100 in 1 CARTON | TABLET | 100 | 18 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51079-735-01 | EA - Each | 51079-735 | 8743d4de-a726-404e-9416-e9f8db6f7836 | 1 | 2012-07-24 |
| 51079-735-20 | EA - Each | 51079-735 | 4f7cd5a0-6eda-4628-bbef-be6d0e9746d3 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| HALOPERIDOL | ACTIVE INGREDIENT | J6292F8L3D | HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.] | 9 | |
| HALOPERIDOL | ACTIVE MOIETY | J6292F8L3D | HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.] | 9 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.] | 9 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.] | 9 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.] | 9 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.] | 9 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.] | 9 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.] | 9 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HALOPERIDOL TABLET [MYLAN INSTITUTIONAL INC.] | 9 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310670 | haloperidol 0.5 MG Oral Tablet | PSN | ad7d2f17-a4e8-4ebc-9baf-5983ac626782 | 18 |
| 310671 | haloperidol 1 MG Oral Tablet | PSN | ad7d2f17-a4e8-4ebc-9baf-5983ac626782 | 18 |
| 314035 | haloperidol 10 MG Oral Tablet | PSN | ad7d2f17-a4e8-4ebc-9baf-5983ac626782 | 18 |
| 314034 | haloperidol 2 MG Oral Tablet | PSN | ad7d2f17-a4e8-4ebc-9baf-5983ac626782 | 18 |
| 310672 | haloperidol 5 MG Oral Tablet | PSN | ad7d2f17-a4e8-4ebc-9baf-5983ac626782 | 18 |
| 310670 | haloperidol 0.5 MG Oral Tablet | SCD | ad7d2f17-a4e8-4ebc-9baf-5983ac626782 | 18 |
| 310671 | haloperidol 1 MG Oral Tablet | SCD | ad7d2f17-a4e8-4ebc-9baf-5983ac626782 | 18 |
| 314035 | haloperidol 10 MG Oral Tablet | SCD | ad7d2f17-a4e8-4ebc-9baf-5983ac626782 | 18 |
| 314034 | haloperidol 2 MG Oral Tablet | SCD | ad7d2f17-a4e8-4ebc-9baf-5983ac626782 | 18 |
| 310672 | haloperidol 5 MG Oral Tablet | SCD | ad7d2f17-a4e8-4ebc-9baf-5983ac626782 | 18 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51079-735-01 | 51079073501 | 1 in 1 BLISTER PACK | Historical | |||||
| 51079-735-20 | 51079073520 | 100 BLISTER PACK in 1 CARTON (51079-735-20) / 1 TABLET in 1 BLISTER PACK (51079-735-01) | 100 blister pack | 2004-02-15 | 0000-00-00 | No | No | Current |