NDC 0132-0217 Phazyme Ultimate
Simethicone Capsule, Liquid Filled Oral

Product Information

Product Code0132-0217
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.
Phazyme Ultimate
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.
Simethicone
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 Otc Drug
Dosage FormCapsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
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.
C.b. Fleet Company, Inc.
Labeler Code0132
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.
part332
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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
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.
02-15-2021
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.
12-31-2022
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

Usage Information


Product Characteristics

Color(s)BLUE (C48333)
ShapeCAPSULE (C48336)
Size(s)11 MM
Imprint(s)PZ500
Score1

Product Packages

NDC 0132-0217-10

Package Description: 1 BLISTER PACK in 1 BOX > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC 0132-0217-20

Package Description: 2 BLISTER PACK in 1 BOX > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Product Details

Phazyme Ultimate is a human over the counter drug product labeled by C.b. Fleet Company, Inc.. The generic name of Phazyme Ultimate is simethicone. The product's dosage form is capsule, liquid filled and is administered via oral form.


What are Phazyme Ultimate Active Ingredients?

The following is the list of active ingredients in this product. 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.

  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • WATER (UNII: 059QF0KO0R)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)


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.

Phazyme Ultimate 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



Purpose



Simethicone 500mg……………………………………Anti-gas


Use



Relieves bloating, pressure, or fullness commonly referred to as gas


Stop Use And Ask A Doctor If



condition persists.


Directions



  • Swallow (1) Fast Gel as symptoms occur
  • Do not exceed (1) Fast Gel per 24 hours except under the advice and supervision of a physician

Other Information



Store at room temperature 59°- 86°F (15°-30°C).


Inactive Ingredients



FD&C Blue #1, gelatin, glycerin, water


Questions?



Call toll-free 1-855-727-4277

TAMPER EVIDENT PACKAGE

Do not use if blister or printed foil is broken or torn, or if “PZ500” is missing from Fast Gel.


Principal Display Panel



PHAZYME® ULTIMATE

ANTI-GAS SIMETHICONE 500 mg

10 fast gels


* Please review the disclaimer below.