haloperidol decanoate

Generic: haloperidol decanoate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name haloperidol decanoate
Generic Name haloperidol decanoate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

haloperidol decanoate 50 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-469
Product ID 63323-469_86dff2aa-2ab3-42fc-989e-619b13ace573
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074893
Listing Expiration 2026-12-31
Marketing Start 2000-02-16

Pharmacologic Class

Classes
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323469
Hyphenated Format 63323-469

Supplemental Identifiers

RxCUI
859867 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 ANDA074893 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (63323-469-01) / 1 mL in 1 VIAL
  • 1 VIAL, MULTI-DOSE in 1 CARTON (63323-469-05) / 5 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (2)

63323-469-01 1 VIAL in 1 CARTON (63323-469-01) / 1 mL in 1 VIAL 63323-469-05 1 VIAL, MULTI-DOSE in 1 CARTON (63323-469-05) / 5 mL in 1 VIAL, MULTI-DOSE

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": "86dff2aa-2ab3-42fc-989e-619b13ace573", "openfda": {"unii": ["AC20PJ4101"], "rxcui": ["859867", "859871", "1719803", "1719862"], "spl_set_id": ["ca9896e0-fb2e-46a4-8700-20d144c14764"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (63323-469-01)  / 1 mL in 1 VIAL", "package_ndc": "63323-469-01", "marketing_start_date": "20000216"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (63323-469-05)  / 5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "63323-469-05", "marketing_start_date": "20000216"}], "brand_name": "Haloperidol Decanoate", "product_id": "63323-469_86dff2aa-2ab3-42fc-989e-619b13ace573", "dosage_form": "INJECTION", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "63323-469", "generic_name": "HALOPERIDOL DECANOATE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Haloperidol Decanoate", "active_ingredients": [{"name": "HALOPERIDOL DECANOATE", "strength": "50 mg/mL"}], "application_number": "ANDA074893", "marketing_category": "ANDA", "marketing_start_date": "20000216", "listing_expiration_date": "20261231"}