haloperidol

Generic: haloperidol lactate

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

Drug Facts

Product Profile

Brand Name haloperidol
Generic Name haloperidol lactate
Labeler remedyrepack inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

haloperidol lactate 5 mg/mL

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-0035
Product ID 70518-0035_47d237d9-837d-6e8b-e063-6394a90a7493
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075689
Listing Expiration 2027-12-31
Marketing Start 2016-12-02

Pharmacologic Class

Classes
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705180035
Hyphenated Format 70518-0035

Supplemental Identifiers

RxCUI
1719646
UNII
6387S86PK3

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 (70518-0035-0) / 1 mL in 1 VIAL
source: ndc

Packages (1)

70518-0035-0 25 VIAL in 1 TRAY (70518-0035-0) / 1 mL in 1 VIAL

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": "47d237d9-837d-6e8b-e063-6394a90a7493", "openfda": {"unii": ["6387S86PK3"], "rxcui": ["1719646"], "spl_set_id": ["e702b2f0-d464-41c3-977a-d37bb22c0ab0"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 TRAY (70518-0035-0)  / 1 mL in 1 VIAL", "package_ndc": "70518-0035-0", "marketing_start_date": "20161202"}], "brand_name": "Haloperidol", "product_id": "70518-0035_47d237d9-837d-6e8b-e063-6394a90a7493", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "70518-0035", "generic_name": "HALOPERIDOL LACTATE", "labeler_name": "REMEDYREPACK INC.", "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": "20161202", "listing_expiration_date": "20271231"}