haloperidol decanoate

Generic: haloperidol decanoate

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name haloperidol decanoate
Generic Name haloperidol decanoate
Labeler bluepoint laboratories
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

haloperidol decanoate 50 mg/mL

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-578
Product ID 68001-578_048557ea-f859-f0f2-e063-6294a90af5ab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209101
Listing Expiration 2026-12-31
Marketing Start 2023-09-15

Pharmacologic Class

Classes
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001578
Hyphenated Format 68001-578

Supplemental Identifiers

RxCUI
859871 1719803 1719862
UPC
0368001578592 0368001581417 0368001579599 0368001582414
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 ANDA209101 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 3 AMPULE in 1 CARTON (68001-578-48) / 1 mL in 1 AMPULE (68001-578-59)
source: ndc

Packages (1)

68001-578-48 3 AMPULE in 1 CARTON (68001-578-48) / 1 mL in 1 AMPULE (68001-578-59)

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": "048557ea-f859-f0f2-e063-6294a90af5ab", "openfda": {"upc": ["0368001578592", "0368001581417", "0368001579599", "0368001582414"], "unii": ["AC20PJ4101"], "rxcui": ["859871", "1719803", "1719862"], "spl_set_id": ["f2d14406-2ad4-4c5b-9c24-a026f27b415d"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 AMPULE in 1 CARTON (68001-578-48)  / 1 mL in 1 AMPULE (68001-578-59)", "package_ndc": "68001-578-48", "marketing_start_date": "20230915"}], "brand_name": "HALOPERIDOL DECANOATE", "product_id": "68001-578_048557ea-f859-f0f2-e063-6294a90af5ab", "dosage_form": "INJECTION", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "68001-578", "generic_name": "HALOPERIDOL DECANOATE", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HALOPERIDOL DECANOATE", "active_ingredients": [{"name": "HALOPERIDOL DECANOATE", "strength": "50 mg/mL"}], "application_number": "ANDA209101", "marketing_category": "ANDA", "marketing_start_date": "20230915", "listing_expiration_date": "20261231"}