haloperidol decanoate

Generic: haloperidol decanoate

Labeler: lifestar pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name haloperidol decanoate
Generic Name haloperidol decanoate
Labeler lifestar pharma llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

haloperidol decanoate 100 mg/mL

Manufacturer
Lifestar Pharma LLC

Identifiers & Regulatory

Product NDC 70756-616
Product ID 70756-616_bae2fb28-774a-44e2-89ed-4412e71f98ec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216730
Listing Expiration 2026-12-31
Marketing Start 2023-05-23

Pharmacologic Class

Classes
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70756616
Hyphenated Format 70756-616

Supplemental Identifiers

RxCUI
859867 859871 1719803 1719862
UPC
0370756615811 0370756624851 0370756616818 0370756625858
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 ANDA216730 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 5 VIAL in 1 CARTON (70756-616-05) / 1 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (70756-616-10) / 1 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (70756-616-81) / 1 mL in 1 VIAL
source: ndc

Packages (3)

70756-616-05 5 VIAL in 1 CARTON (70756-616-05) / 1 mL in 1 VIAL 70756-616-10 10 VIAL in 1 CARTON (70756-616-10) / 1 mL in 1 VIAL 70756-616-81 1 VIAL in 1 CARTON (70756-616-81) / 1 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": "bae2fb28-774a-44e2-89ed-4412e71f98ec", "openfda": {"upc": ["0370756615811", "0370756624851", "0370756616818", "0370756625858"], "unii": ["AC20PJ4101"], "rxcui": ["859867", "859871", "1719803", "1719862"], "spl_set_id": ["8a96195e-97cd-4161-96e0-494a1636fa9c"], "manufacturer_name": ["Lifestar Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL in 1 CARTON (70756-616-05)  / 1 mL in 1 VIAL", "package_ndc": "70756-616-05", "marketing_start_date": "20230523"}, {"sample": false, "description": "10 VIAL in 1 CARTON (70756-616-10)  / 1 mL in 1 VIAL", "package_ndc": "70756-616-10", "marketing_start_date": "20230523"}, {"sample": false, "description": "1 VIAL in 1 CARTON (70756-616-81)  / 1 mL in 1 VIAL", "package_ndc": "70756-616-81", "marketing_start_date": "20230523"}], "brand_name": "Haloperidol Decanoate", "product_id": "70756-616_bae2fb28-774a-44e2-89ed-4412e71f98ec", "dosage_form": "INJECTION", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "70756-616", "generic_name": "Haloperidol Decanoate", "labeler_name": "Lifestar Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Haloperidol Decanoate", "active_ingredients": [{"name": "HALOPERIDOL DECANOATE", "strength": "100 mg/mL"}], "application_number": "ANDA216730", "marketing_category": "ANDA", "marketing_start_date": "20230523", "listing_expiration_date": "20261231"}