haloperidol decanoate (70069-383)

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 70069-383

Product ID 70069-383_f6d888a0-65a7-4073-8671-b00b4bfaff4c

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA209101

Listing Expiration 2026-12-31

Marketing Start 2019-04-04

Pharmacologic Class

Classes

typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069383

Hyphenated Format 70069-383

Supplemental Identifiers

RxCUI

859867 859871 1719803 1719862

UPC

0370069382011 0370069383018 0370069031018 0370069030011 0370069384015

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

100 mg/mL

source: ndc

Packaging

1 VIAL, SINGLE-DOSE in 1 CARTON (70069-383-01) / 1 mL in 1 VIAL, SINGLE-DOSE
5 VIAL, SINGLE-DOSE in 1 CARTON (70069-383-05) / 1 mL in 1 VIAL, SINGLE-DOSE
10 VIAL, SINGLE-DOSE in 1 CARTON (70069-383-10) / 1 mL in 1 VIAL, SINGLE-DOSE

source: ndc

Packages (3)

70069-383-01 1 VIAL, SINGLE-DOSE in 1 CARTON (70069-383-01) / 1 mL in 1 VIAL, SINGLE-DOSE 70069-383-05 5 VIAL, SINGLE-DOSE in 1 CARTON (70069-383-05) / 1 mL in 1 VIAL, SINGLE-DOSE 70069-383-10 10 VIAL, SINGLE-DOSE in 1 CARTON (70069-383-10) / 1 mL in 1 VIAL, SINGLE-DOSE

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": "f6d888a0-65a7-4073-8671-b00b4bfaff4c", "openfda": {"upc": ["0370069382011", "0370069383018", "0370069031018", "0370069030011", "0370069384015"], "unii": ["AC20PJ4101"], "rxcui": ["859867", "859871", "1719803", "1719862"], "spl_set_id": ["f2bff27f-929f-4f7d-b3eb-084ebc2a885f"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (70069-383-01)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "70069-383-01", "marketing_start_date": "20191004"}, {"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 CARTON (70069-383-05)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "70069-383-05", "marketing_start_date": "20190404"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (70069-383-10)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "70069-383-10", "marketing_start_date": "20190413"}], "brand_name": "HALOPERIDOL DECANOATE", "product_id": "70069-383_f6d888a0-65a7-4073-8671-b00b4bfaff4c", "dosage_form": "INJECTION", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "70069-383", "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": "ANDA209101", "marketing_category": "ANDA", "marketing_start_date": "20190404", "listing_expiration_date": "20261231"}