NDC 68084-950 Fluphenazine Hydrochloride
Tablet, Film Coated Oral

Product Information

Fluphenazine Hydrochloride is a human prescription drug product labeled by American Health Packaging. The product's dosage form is tablet, film coated and is administered via oral form.

Product Code68084-950
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Fluphenazine Hydrochloride
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Fluphenazine Hydrochloride
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormTablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
American Health Packaging
Labeler Code68084
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
ANDA089743
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
10-01-2015
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Fluphenazine Hydrochloride?


Product Characteristics

Color(s)PINK (C48328 - DARK PINK)
ORANGE (C48331)
ShapeROUND (C48348)
Size(s)8 MM
10 MM
Imprint(s)LCI;1790
LCI;1791
Score1

Product Packages

NDC 68084-950-01

Package Description: 100 BLISTER PACK in 1 BOX, UNIT-DOSE > 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-950-11)

Price per Unit: $2.05876 per EA

Product Details

What are Fluphenazine Hydrochloride Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.
  • STARCH, CORN (UNII: O8232NY3SJ)
  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • D&C RED NO. 30 (UNII: 2S42T2808B)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • WATER (UNII: 059QF0KO0R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • WATER (UNII: 059QF0KO0R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Patient Education

Fluphenazine

Fluphenazine is pronounced as (floo fen' a zeen)

Why is fluphenazine medication prescribed?
Fluphenazine is an antipsychotic medication used to treat schizophrenia and psychotic symptoms such as hallucinations, delusions, and hostility.This medication is sometim...
[Read More]

* Please review the disclaimer below.

Fluphenazine Hydrochloride Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Falls



Fluphenazine hydrochloride tablets, USP may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.


Packaging Information



American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Lannett Company, Inc. as follows:
(5 mg / 30 UD) NDC 68084-846-25 packaged from NDC 0527-1790
(10 mg / 30 UD) NDC 68084-950-25 packaged from NDC 0527-1791

Distributed by:
American Health Packaging
Columbus, OH 43217

8284625/1017F


Package/Label Display Panel – Carton – 5 Mg



NDC 68084-846-25

Fluphenazine
Hydrochloride
Tablets, USP

5 mg

30 Tablets (5 x 6)

Each Tablet Contains:
Fluphenazine Hydrochloride, USP …………………….. 5 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature]. Avoid excessive heat. Protect from
light.

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn
or broken.

Rx Only

The drug product contained in this package is from
NDC # 0527-1790, Lannett Company, Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

084625
0284625/0817OS


Package/Label Display Panel – Blister – 5 Mg



Fluphenazine
Hydrochloride
Tablet, USP

5 mg


Package/Label Display Panel – Carton – 10 Mg



NDC 68084-950-25

Fluphenazine
Hydrochloride
Tablets, USP

10 mg

30 Tablets (5 x 6)

Each Tablet Contains:
Fluphenazine Hydrochloride, USP …………………….. 10 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature]. Avoid excessive heat. Protect from
light.

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn
or broken.

Rx Only

The drug product contained in this package is from
NDC # 0527-1791, Lannett Company, Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

095025
0295025/0717OS


Package/Label Display Panel – Blister – 10 Mg



Fluphenazine
Hydrochloride
Tablet, USP

10 mg


* Please review the disclaimer below.