haloperidol decanoate

Generic: haloperidol decanoate

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name haloperidol decanoate
Generic Name haloperidol decanoate
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

haloperidol decanoate 100 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-138
Product ID 68083-138_da8f2d81-a122-4fe4-8f43-f2fe611d69c9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205241
Listing Expiration 2026-12-31
Marketing Start 2017-01-16

Pharmacologic Class

Classes
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083138
Hyphenated Format 68083-138

Supplemental Identifiers

RxCUI
859867 859871 1719803 1719862
UPC
0368083137106 0368083138103
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 ANDA205241 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68083-138-02) / 5 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (68083-138-10) / 1 mL in 1 VIAL
source: ndc

Packages (2)

68083-138-02 1 VIAL in 1 CARTON (68083-138-02) / 5 mL in 1 VIAL 68083-138-10 10 VIAL in 1 CARTON (68083-138-10) / 1 mL in 1 VIAL

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": "da8f2d81-a122-4fe4-8f43-f2fe611d69c9", "openfda": {"upc": ["0368083137106", "0368083138103"], "unii": ["AC20PJ4101"], "rxcui": ["859867", "859871", "1719803", "1719862"], "spl_set_id": ["1a0e38cb-fd9f-4962-9f81-5c0023ca6b4c"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-138-02)  / 5 mL in 1 VIAL", "package_ndc": "68083-138-02", "marketing_start_date": "20170116"}, {"sample": false, "description": "10 VIAL in 1 CARTON (68083-138-10)  / 1 mL in 1 VIAL", "package_ndc": "68083-138-10", "marketing_start_date": "20170116"}], "brand_name": "Haloperidol Decanoate", "product_id": "68083-138_da8f2d81-a122-4fe4-8f43-f2fe611d69c9", "dosage_form": "INJECTION", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "68083-138", "generic_name": "Haloperidol Decanoate", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Haloperidol Decanoate", "active_ingredients": [{"name": "HALOPERIDOL DECANOATE", "strength": "100 mg/mL"}], "application_number": "ANDA205241", "marketing_category": "ANDA", "marketing_start_date": "20170116", "listing_expiration_date": "20261231"}