haloperidol decanoate

Generic: haloperidol decanoate

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name haloperidol decanoate
Generic Name haloperidol decanoate
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

haloperidol decanoate 100 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-504
Product ID 71288-504_0018ab14-a6f5-4452-be9f-bd34cd1f4309
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214507
Listing Expiration 2026-12-31
Marketing Start 2021-07-26

Pharmacologic Class

Classes
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288504
Hyphenated Format 71288-504

Supplemental Identifiers

RxCUI
859871 1719803 1719862
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 ANDA214507 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (71288-504-05) / 5 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

71288-504-05 1 VIAL, MULTI-DOSE in 1 CARTON (71288-504-05) / 5 mL in 1 VIAL, MULTI-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": "0018ab14-a6f5-4452-be9f-bd34cd1f4309", "openfda": {"unii": ["AC20PJ4101"], "rxcui": ["859871", "1719803", "1719862"], "spl_set_id": ["14f40303-9604-4a30-8e86-8abaeb177ce1"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (71288-504-05)  / 5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "71288-504-05", "marketing_start_date": "20210726"}], "brand_name": "Haloperidol Decanoate", "product_id": "71288-504_0018ab14-a6f5-4452-be9f-bd34cd1f4309", "dosage_form": "INJECTION", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "71288-504", "generic_name": "Haloperidol Decanoate", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Haloperidol Decanoate", "active_ingredients": [{"name": "HALOPERIDOL DECANOATE", "strength": "100 mg/mL"}], "application_number": "ANDA214507", "marketing_category": "ANDA", "marketing_start_date": "20210726", "listing_expiration_date": "20261231"}