| Product NDC: | 53150-422 |
| Proprietary Name: | Haloperidol Decanoate |
| Non Proprietary Name: | Haloperidol Decanoate |
| Active Ingredient(s): | 50 mg/mL & nbsp; Haloperidol Decanoate |
| Administration Route(s): | INTRAMUSCULAR |
| Dosage Form(s): | INJECTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 53150-422 |
| Labeler Name: | Amneal-Agila, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA075440 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20130423 |
| Package NDC: | 53150-422-05 |
| Package Description: | 5 VIAL, MULTI-DOSE in 1 CARTON (53150-422-05) > 5 mL in 1 VIAL, MULTI-DOSE (53150-422-01) |
| NDC Code | 53150-422-05 |
| Proprietary Name | Haloperidol Decanoate |
| Package Description | 5 VIAL, MULTI-DOSE in 1 CARTON (53150-422-05) > 5 mL in 1 VIAL, MULTI-DOSE (53150-422-01) |
| Product NDC | 53150-422 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Haloperidol Decanoate |
| Dosage Form Name | INJECTION |
| Route Name | INTRAMUSCULAR |
| Start Marketing Date | 20130423 |
| Marketing Category Name | ANDA |
| Labeler Name | Amneal-Agila, LLC |
| Substance Name | HALOPERIDOL DECANOATE |
| Strength Number | 50 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Typical Antipsychotic [EPC] |