Haloperidol
- Product NDC
- 0378-0335
- 11-digit product format
- 003780335
- Labeler code
- 0378
- Product ID
- 0378-0335_746dbc60-6679-4e9a-bc8f-c573c693be32
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- haloperidol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA070278
- Marketing category
- ANDA
- Marketing start
- 2009-07-17
- Marketing end
- 2025-05-31
- Substance
- HALOPERIDOL
- Active strength
- 20 mg/1
- Pharmacologic classes
- Typical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-0335-01 | Haloperidol | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 22 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HALOPERIDOL | ACTIVE INGREDIENT | J6292F8L3D | HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.] | 11 | |
| HALOPERIDOL | ACTIVE MOIETY | J6292F8L3D | HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.] | 11 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.] | 11 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.] | 11 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.] | 11 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.] | 11 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.] | 11 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.] | 11 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.] | 11 | |
| HALOPERIDOL | ACTIVE INGREDIENT | J6292F8L3D | HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| HALOPERIDOL | ACTIVE MOIETY | J6292F8L3D | HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HALOPERIDOL TABLET [PHYSICIANS TOTAL CARE, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-0335 | HALOPERIDOL TABLET [MYLAN PHARMACEUTICALS INC.] | 21 | Legacy NDC, 1 package rows | 20250326_c559b0b0-4087-d12a-e718-c18ccb6811e6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-0335-01 | 00378033501 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0335-01) | 100 tablet | 2009-07-17 | 0000-00-00 | No | No | Current |