fluphenazine hydrochloride

Generic: fluphenazine hydrochloride

Labeler: upsher-smith laboratories,llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluphenazine hydrochloride
Generic Name fluphenazine hydrochloride
Labeler upsher-smith laboratories,llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fluphenazine hydrochloride 1 mg/1

Manufacturer
Upsher-Smith Laboratories,LLC

Identifiers & Regulatory

Product NDC 0832-6003
Product ID 0832-6003_3bb74f82-8872-9829-e063-6294a90aeace
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213784
Marketing Start 2022-11-22
Marketing End 2027-07-31

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 08326003
Hyphenated Format 0832-6003

Supplemental Identifiers

RxCUI
859841 860918 865117 865123
UPC
0308326006110 0308326004116
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 ANDA213784 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • HOW SUPPLIED Fluphenazine hydrochloride tablets, USP, 1 mg tablets are white colored, round shaped, biconvex, beveled edged, film coated tablets, debossed with "ZN" on one side and "L1" on the other side. They are supplied as follows: Bottles of 100, NDC 0832-6003-11 Fluphenazine hydrochloride tablets, USP, 2.5 mg tablets are blue colored, round shaped, biconvex, beveled edged, film coated tablets, debossed with "ZN" on one side and "L2" on the other side. They are supplied as follows: Bottles of 100, NDC 0832-6004-11 Fluphenazine hydrochloride tablets, USP, 5 mg tablets are pink colored, round shaped, biconvex, beveled edged, film coated tablets, debossed with "ZNL" on one side and "5" on the other side. They are supplied as follows: Bottles of 100, NDC 0832-6005-11 Fluphenazine hydrochloride tablets, USP, 10 mg tablets are orange colored, round shaped, biconvex, beveled edged, film coated tablets, debossed with "ZNL" on one side and "10" on the other side. They are supplied as follows: Bottles of 100, NDC 0832-6006-11 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid excessive heat. Protect from light. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.
  • PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label NDC 0832-6003-11 Fluphenazine Hydrochloride Tablets, USP 1 mg 100 Tablets Rx only UPSHER-SMITH PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 2.5 mg Tablet Bottle Label NDC 0832-6004-11 Fluphenazine Hydrochloride Tablets, USP 2.5 mg 100 Tablets Rx only UPSHER-SMITH PRINCIPAL DISPLAY PANEL - 2.5 mg Tablet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 5 mg Tablet Bottle Label NDC 0832-6005-11 Fluphenazine Hydrochloride Tablets, USP 5 mg 100 Tablets Rx only UPSHER-SMITH PRINCIPAL DISPLAY PANEL - 5 mg Tablet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label NDC 0832-6006-11 Fluphenazine Hydrochloride Tablets, USP 10 mg 100 Tablets Rx only UPSHER-SMITH PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label
source: label

Packages (0)

No package records.

Ingredients (1)

fluphenazine hydrochloride (1 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": "3bb74f82-8872-9829-e063-6294a90aeace", "openfda": {"upc": ["0308326006110", "0308326004116"], "unii": ["ZOU145W1XL"], "rxcui": ["859841", "860918", "865117", "865123"], "spl_set_id": ["f07bb3f1-c68c-441b-9de4-99a219f2500a"], "manufacturer_name": ["Upsher-Smith Laboratories,LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Fluphenazine Hydrochloride", "product_id": "0832-6003_3bb74f82-8872-9829-e063-6294a90aeace", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "0832-6003", "generic_name": "Fluphenazine Hydrochloride", "labeler_name": "Upsher-Smith Laboratories,LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluphenazine Hydrochloride", "active_ingredients": [{"name": "FLUPHENAZINE HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "ANDA213784", "marketing_category": "ANDA", "marketing_end_date": "20270731", "marketing_start_date": "20221122"}