haloperidol

Generic: haloperidol lactate

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

Drug Facts

Product Profile

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

haloperidol lactate 5 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-474
Product ID 63323-474_f3409439-088d-49ec-9e10-c6c3b1a07eef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075689
Listing Expiration 2026-12-31
Marketing Start 2000-10-20

Pharmacologic Class

Classes
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323474
Hyphenated Format 63323-474

Supplemental Identifiers

RxCUI
204416 1719646
UPC
0363323474102 0363323474003
UNII
6387S86PK3

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 (source: ndc)
Generic Name haloperidol lactate (source: ndc)
Application Number ANDA075689 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 TRAY (63323-474-01) / 1 mL in 1 VIAL (63323-474-00)
  • 1 VIAL, MULTI-DOSE in 1 BOX (63323-474-10) / 10 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (2)

63323-474-01 25 VIAL in 1 TRAY (63323-474-01) / 1 mL in 1 VIAL (63323-474-00) 63323-474-10 1 VIAL, MULTI-DOSE in 1 BOX (63323-474-10) / 10 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

haloperidol lactate (5 mg/mL)

Linked Drug Pages (1)

Haloperidol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "f3409439-088d-49ec-9e10-c6c3b1a07eef", "openfda": {"upc": ["0363323474102", "0363323474003"], "unii": ["6387S86PK3"], "rxcui": ["204416", "1719646"], "spl_set_id": ["b1ad2abd-a9d6-44e3-957b-36a73260f4f5"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 TRAY (63323-474-01)  / 1 mL in 1 VIAL (63323-474-00)", "package_ndc": "63323-474-01", "marketing_start_date": "20001020"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 BOX (63323-474-10)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "63323-474-10", "marketing_start_date": "20001020"}], "brand_name": "Haloperidol", "product_id": "63323-474_f3409439-088d-49ec-9e10-c6c3b1a07eef", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "63323-474", "generic_name": "HALOPERIDOL LACTATE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Haloperidol", "active_ingredients": [{"name": "HALOPERIDOL LACTATE", "strength": "5 mg/mL"}], "application_number": "ANDA075689", "marketing_category": "ANDA", "marketing_start_date": "20001020", "listing_expiration_date": "20261231"}