haloperidol decanoate

Generic: haloperidol decanoate

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name haloperidol decanoate
Generic Name haloperidol decanoate
Labeler remedyrepack inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

haloperidol decanoate 50 mg/mL

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3743
Product ID 70518-3743_3b15bc87-6f04-66bc-e063-6294a90a9bbd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214507
Listing Expiration 2026-12-31
Marketing Start 2023-06-02

Pharmacologic Class

Classes
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183743
Hyphenated Format 70518-3743

Supplemental Identifiers

RxCUI
1719862
UNII
AC20PJ4101

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name haloperidol decanoate (source: ndc)
Generic Name haloperidol decanoate (source: ndc)
Application Number ANDA214507 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (70518-3743-0) / 1 mL in 1 VIAL, SINGLE-DOSE (70518-3743-1)
source: ndc

Packages (1)

70518-3743-0 10 VIAL, SINGLE-DOSE in 1 CARTON (70518-3743-0) / 1 mL in 1 VIAL, SINGLE-DOSE (70518-3743-1)

Ingredients (1)

haloperidol decanoate (50 mg/mL)

Linked Drug Pages (1)

Haloperidol Decanoate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "3b15bc87-6f04-66bc-e063-6294a90a9bbd", "openfda": {"unii": ["AC20PJ4101"], "rxcui": ["1719862"], "spl_set_id": ["4a3653df-84c7-46c2-b8fd-28c63cd2747a"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (70518-3743-0)  / 1 mL in 1 VIAL, SINGLE-DOSE (70518-3743-1)", "package_ndc": "70518-3743-0", "marketing_start_date": "20230602"}], "brand_name": "Haloperidol Decanoate", "product_id": "70518-3743_3b15bc87-6f04-66bc-e063-6294a90a9bbd", "dosage_form": "INJECTION", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "70518-3743", "generic_name": "Haloperidol Decanoate", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Haloperidol Decanoate", "active_ingredients": [{"name": "HALOPERIDOL DECANOATE", "strength": "50 mg/mL"}], "application_number": "ANDA214507", "marketing_category": "ANDA", "marketing_start_date": "20230602", "listing_expiration_date": "20261231"}