haloperidol decanoate

Generic: haloperidol decanoate

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name haloperidol decanoate
Generic Name haloperidol decanoate
Labeler mylan institutional llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

haloperidol decanoate 50 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-410
Product ID 67457-410_de6fba7e-eade-43a8-aa68-5b84bf3aa086
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075440
Listing Expiration 2026-12-31
Marketing Start 2013-04-23

Pharmacologic Class

Classes
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457410
Hyphenated Format 67457-410

Supplemental Identifiers

RxCUI
859867 859871 1719803 1719862
UPC
0367457409139 0367457381589 0367457382586
UNII
AC20PJ4101

Packaging Origin

Original Packager
true

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 ANDA075440 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (67457-410-13) / 1 mL in 1 VIAL (67457-410-00)
source: ndc

Packages (1)

67457-410-13 10 VIAL in 1 CARTON (67457-410-13) / 1 mL in 1 VIAL (67457-410-00)

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": "de6fba7e-eade-43a8-aa68-5b84bf3aa086", "openfda": {"upc": ["0367457409139", "0367457381589", "0367457382586"], "unii": ["AC20PJ4101"], "rxcui": ["859867", "859871", "1719803", "1719862"], "spl_set_id": ["8ffac6fb-1702-40d6-b085-152d24673cbd"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (67457-410-13)  / 1 mL in 1 VIAL (67457-410-00)", "package_ndc": "67457-410-13", "marketing_start_date": "20130423"}], "brand_name": "Haloperidol Decanoate", "product_id": "67457-410_de6fba7e-eade-43a8-aa68-5b84bf3aa086", "dosage_form": "INJECTION", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "67457-410", "generic_name": "Haloperidol Decanoate", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Haloperidol Decanoate", "active_ingredients": [{"name": "HALOPERIDOL DECANOATE", "strength": "50 mg/mL"}], "application_number": "ANDA075440", "marketing_category": "ANDA", "marketing_start_date": "20130423", "listing_expiration_date": "20261231"}