fluphenazine hydrochloride

Generic: fluphenazine hydrochloride

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluphenazine hydrochloride
Generic Name fluphenazine hydrochloride
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fluphenazine hydrochloride 5 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-337
Product ID 68462-337_b5186569-6be5-4ff2-a95e-f162f76254d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216350
Listing Expiration 2027-12-31
Marketing Start 2023-11-06

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462337
Hyphenated Format 68462-337

Supplemental Identifiers

RxCUI
859841 860918 865117 865123
UPC
0368462338018 0368462337011 0368462914014 0368462336014
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 ANDA216350 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68462-337-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68462-337-05)
  • 100 BLISTER PACK in 1 CARTON (68462-337-14) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (3)

68462-337-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68462-337-01) 68462-337-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68462-337-05) 68462-337-14 100 BLISTER PACK in 1 CARTON (68462-337-14) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

fluphenazine hydrochloride (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": "b5186569-6be5-4ff2-a95e-f162f76254d9", "openfda": {"upc": ["0368462338018", "0368462337011", "0368462914014", "0368462336014"], "unii": ["ZOU145W1XL"], "rxcui": ["859841", "860918", "865117", "865123"], "spl_set_id": ["4c3eea71-a7a1-4eda-9871-034ddeb83ed6"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68462-337-01)", "package_ndc": "68462-337-01", "marketing_start_date": "20231106"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68462-337-05)", "package_ndc": "68462-337-05", "marketing_start_date": "20231106"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (68462-337-14)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "68462-337-14", "marketing_start_date": "20231106"}], "brand_name": "Fluphenazine Hydrochloride", "product_id": "68462-337_b5186569-6be5-4ff2-a95e-f162f76254d9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "68462-337", "generic_name": "Fluphenazine Hydrochloride", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluphenazine Hydrochloride", "active_ingredients": [{"name": "FLUPHENAZINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA216350", "marketing_category": "ANDA", "marketing_start_date": "20231106", "listing_expiration_date": "20271231"}