NDC 70000-0031 Phenazopyridine Hydrochloride

Phenazopyridine Hydrochloride

NDC Product Code 70000-0031

NDC Code: 70000-0031

Proprietary Name: Phenazopyridine Hydrochloride 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.

Non-Proprietary Name: Phenazopyridine Hydrochloride 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.

Product Characteristics

Color(s):
RED (C48326)
Shape: ROUND (C48348)
Size(s):
7 MM
Imprint(s):
CPC;64
Score: 1

NDC Code Structure

  • 70000 - Cardinal Health
    • 70000-0031 - Phenazopyridine Hydrochloride

NDC 70000-0031-1

Package Description: 1 BLISTER PACK in 1 CARTON > 30 TABLET, FILM COATED in 1 BLISTER PACK

NDC Product Information

Phenazopyridine Hydrochloride with NDC 70000-0031 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Phenazopyridine Hydrochloride is phenazopyridine hydrochloride. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Cardinal Health

Dosage Form: Tablet, 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.

Product Type: Human Otc Drug 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.

Phenazopyridine Hydrochloride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1

Inactive Ingredient(s)

About the 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.

  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • POVIDONE K30 (UNII: U725QWY32X)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • CROSCARMELLOSE (UNII: 029TFK992N)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)

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.

Labeler Name: Cardinal Health
Labeler Code: 70000
Marketing Category: UNAPPROVED DRUG OTHER - 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.

Start Marketing Date: 05-15-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Phenazopyridine

Phenazopyridine is pronounced as (fen az oh peer' i deen)

Why is phenazopyridine medication prescribed?
Phenazopyridine relieves urinary tract pain, burning, irritation, and discomfort, as well as urgent and frequent urination caused by urinary tract infections, surgery, in...
[Read More]

* Please review the disclaimer below.

Phenazopyridine Hydrochloride Product Label Images

Phenazopyridine Hydrochloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Drug Facts

Active ingredient (in each tablet) Phenazopyridine Hydrochloride 95 mg

Otc - Purpose

PurposeUrinary tract analgesic

Use

Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.

Warnings

Do not exceed recommended dosage

Otc - Ask Doctor

Ask a doctor before use if you have ■ kidney disease■ allergies to foods, preservatives or dyes■ had a hypersensitive reaction to Phenazopyridine Hydrochloride

Otc - Do Not Use

Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.

Otc - When Using

When using this product■ stomach upset may occur, taking this product with or after meals may reduce stomach upset■ your urine will become reddish-orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items.

Otc - Stop Use

Stop use and ask a doctor if ■ your symptoms last for more than 2 days■ you suspect you are having an adverse reaction to the medication.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.
A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

In case of an overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions


adults and children 12 years of age and over: Take 2 tablets 3 times daily with a full glass of water, with or after meals as needed.

children under 12 years of age: consult a doctor

Do not use for more than 2 days (12 tablets) without consulting a doctor

Other Information

■ This product may stain contact lenses and other items if handled after touching tablets■ This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests■ Long term administration of phenazopyridine HCI has induced neoplasia in rats (large intestine) and mice (liver). Although no association between phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted■ Store at room temperature 15°-30°C (59°-86°F) in a dry place and protect from light.

Inactive Ingredient

Carnauba wax, corn starch, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch and silica.

Other

CAUTION: TABLETS SEALED IN BLISTER. DO NOT USE IF BLISTER IS OPENED OR DAMAGED.KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATIONWARNING This product can expose you to Phenazopyridine Hydrochloride, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov
*This product is not manufactured or distributed by i-Health, Inc., owner of the registered trademark AZO Urinary Pain Relief®.DISTRIBUTED BYCARDINAL HEALTHDUBLIN, OHIO 43017www.myleader.com1-800-200-6313Essential to Care™ since 19792019 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

* Please review the disclaimer below.

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