fluphenazine hydrochloride

Generic: fluphenazine hydrochloride

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluphenazine hydrochloride
Generic Name fluphenazine hydrochloride
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fluphenazine hydrochloride 2.5 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-789
Product ID 46708-789_7c29fb1f-9403-4e55-abd9-36adfb152e8e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218173
Listing Expiration 2026-12-31
Marketing Start 2024-07-25

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708789
Hyphenated Format 46708-789

Supplemental Identifiers

RxCUI
859841 860918 865117 865123
UPC
0346708788315 0346708789312 0346708791315 0346708790318
UNII
ZOU145W1XL

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 fluphenazine hydrochloride (source: ndc)
Generic Name fluphenazine hydrochloride (source: ndc)
Application Number ANDA218173 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (46708-789-31)
  • 500 TABLET, FILM COATED in 1 BOTTLE (46708-789-71)
source: ndc

Packages (2)

46708-789-31 100 TABLET, FILM COATED in 1 BOTTLE (46708-789-31) 46708-789-71 500 TABLET, FILM COATED in 1 BOTTLE (46708-789-71)

Ingredients (1)

fluphenazine hydrochloride (2.5 mg/1)

Linked Drug Pages (1)

Fluphenazine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7c29fb1f-9403-4e55-abd9-36adfb152e8e", "openfda": {"upc": ["0346708788315", "0346708789312", "0346708791315", "0346708790318"], "unii": ["ZOU145W1XL"], "rxcui": ["859841", "860918", "865117", "865123"], "spl_set_id": ["7c29fb1f-9403-4e55-abd9-36adfb152e8e"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (46708-789-31)", "package_ndc": "46708-789-31", "marketing_start_date": "20240725"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (46708-789-71)", "package_ndc": "46708-789-71", "marketing_start_date": "20240725"}], "brand_name": "Fluphenazine Hydrochloride", "product_id": "46708-789_7c29fb1f-9403-4e55-abd9-36adfb152e8e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "46708-789", "generic_name": "Fluphenazine Hydrochloride", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluphenazine Hydrochloride", "active_ingredients": [{"name": "FLUPHENAZINE HYDROCHLORIDE", "strength": "2.5 mg/1"}], "application_number": "ANDA218173", "marketing_category": "ANDA", "marketing_start_date": "20240725", "listing_expiration_date": "20261231"}