haloperidol decanoate

Generic: haloperidol decanoate

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name haloperidol decanoate
Generic Name haloperidol decanoate
Labeler caplin steriles limited
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

haloperidol decanoate 50 mg/mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-168
Product ID 65145-168_4f9af14a-38c4-4826-aca0-3501edb854e3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219168
Listing Expiration 2026-12-31
Marketing Start 2025-05-26

Pharmacologic Class

Classes
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65145168
Hyphenated Format 65145-168

Supplemental Identifiers

RxCUI
859871 1719803 1719862
UPC
0365145168108 0365145167019 0365145167101 0365145169013 0365145168016
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
  • 50 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (65145-168-10) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-168-01)
source: ndc

Packages (1)

65145-168-10 10 VIAL, SINGLE-DOSE in 1 CARTON (65145-168-10) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-168-01)

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": "4f9af14a-38c4-4826-aca0-3501edb854e3", "openfda": {"upc": ["0365145168108", "0365145167019", "0365145167101", "0365145169013", "0365145168016"], "unii": ["AC20PJ4101"], "rxcui": ["859871", "1719803", "1719862"], "spl_set_id": ["4f9af14a-38c4-4826-aca0-3501edb854e3"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (65145-168-10)  / 1 mL in 1 VIAL, SINGLE-DOSE (65145-168-01)", "package_ndc": "65145-168-10", "marketing_start_date": "20250526"}], "brand_name": "Haloperidol Decanoate", "product_id": "65145-168_4f9af14a-38c4-4826-aca0-3501edb854e3", "dosage_form": "INJECTION", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "65145-168", "generic_name": "Haloperidol Decanoate", "labeler_name": "Caplin Steriles Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Haloperidol Decanoate", "active_ingredients": [{"name": "HALOPERIDOL DECANOATE", "strength": "50 mg/mL"}], "application_number": "ANDA219168", "marketing_category": "ANDA", "marketing_start_date": "20250526", "listing_expiration_date": "20261231"}