haloperidol decanoate

Generic: haloperidol decanoate

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name haloperidol decanoate
Generic Name haloperidol decanoate
Labeler zydus lifesciences limited
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

haloperidol decanoate 100 mg/mL

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1853
Product ID 70771-1853_04562fb6-450e-4345-ac35-6bc8c940682a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211180
Listing Expiration 2026-12-31
Marketing Start 2019-11-14

Pharmacologic Class

Classes
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707711853
Hyphenated Format 70771-1853

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 ANDA211180 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (70771-1853-1) / 1 mL in 1 VIAL, SINGLE-DOSE
  • 5 VIAL, SINGLE-DOSE in 1 CARTON (70771-1853-5) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

70771-1853-1 1 VIAL, SINGLE-DOSE in 1 CARTON (70771-1853-1) / 1 mL in 1 VIAL, SINGLE-DOSE 70771-1853-5 5 VIAL, SINGLE-DOSE in 1 CARTON (70771-1853-5) / 1 mL in 1 VIAL, SINGLE-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": "04562fb6-450e-4345-ac35-6bc8c940682a", "openfda": {"unii": ["AC20PJ4101"], "rxcui": ["859867", "859871", "1719803", "1719862"], "spl_set_id": ["d21796e5-9f29-4c0a-8eed-70aeb9f0e5e9"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (70771-1853-1)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "70771-1853-1", "marketing_start_date": "20191114"}, {"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 CARTON (70771-1853-5)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "70771-1853-5", "marketing_start_date": "20191114"}], "brand_name": "Haloperidol decanoate", "product_id": "70771-1853_04562fb6-450e-4345-ac35-6bc8c940682a", "dosage_form": "INJECTION", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "70771-1853", "generic_name": "Haloperidol decanoate", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Haloperidol decanoate", "active_ingredients": [{"name": "HALOPERIDOL DECANOATE", "strength": "100 mg/mL"}], "application_number": "ANDA211180", "marketing_category": "ANDA", "marketing_start_date": "20191114", "listing_expiration_date": "20261231"}