haloperidol decanoate

Generic: haloperidol decanoate

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name haloperidol decanoate
Generic Name haloperidol decanoate
Labeler somerset therapeutics, llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

haloperidol decanoate 100 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-868
Product ID 70069-868_75154f5d-21e4-4278-85f9-78a4a4e85741
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219168
Listing Expiration 2026-12-31
Marketing Start 2025-09-29

Pharmacologic Class

Classes
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069868
Hyphenated Format 70069-868

Supplemental Identifiers

RxCUI
859871 1719803 1719862
UPC
0370069868010 0370069867013
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 ANDA219168 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (70069-868-01) / 5 mL in 1 VIAL
source: ndc

Packages (1)

70069-868-01 1 VIAL in 1 CARTON (70069-868-01) / 5 mL in 1 VIAL

Ingredients (1)

haloperidol decanoate (100 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": "75154f5d-21e4-4278-85f9-78a4a4e85741", "openfda": {"upc": ["0370069868010", "0370069867013"], "unii": ["AC20PJ4101"], "rxcui": ["859871", "1719803", "1719862"], "spl_set_id": ["068fc913-779d-44c6-9585-3aa80e751bee"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (70069-868-01)  / 5 mL in 1 VIAL", "package_ndc": "70069-868-01", "marketing_start_date": "20250929"}], "brand_name": "HALOPERIDOL DECANOATE", "product_id": "70069-868_75154f5d-21e4-4278-85f9-78a4a4e85741", "dosage_form": "INJECTION", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "70069-868", "generic_name": "HALOPERIDOL DECANOATE", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HALOPERIDOL DECANOATE", "active_ingredients": [{"name": "HALOPERIDOL DECANOATE", "strength": "100 mg/mL"}], "application_number": "ANDA219168", "marketing_category": "ANDA", "marketing_start_date": "20250929", "listing_expiration_date": "20261231"}