NDC 73581-107 Pinrid

Pyrantel Pamoate

NDC Product Code 73581-107

NDC CODE: 73581-107

Proprietary Name: Pinrid 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: Pyrantel Pamoate 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):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
11 MM
Imprint(s):
WM1
Score: 1

NDC Code Structure

NDC 73581-107-12

Package Description: 12 TABLET in 1 BOTTLE

NDC 73581-107-24

Package Description: 24 TABLET in 1 BOTTLE

NDC Product Information

Pinrid with NDC 73581-107 is a a human over the counter drug product labeled by Yyba Corp. The generic name of Pinrid is pyrantel pamoate. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Yyba Corp

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Pinrid 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.

  • PYRANTEL PAMOATE 250 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.

  • ASPARTAME (UNII: Z0H242BBR1)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • DEXTROSE (UNII: IY9XDZ35W2)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • SORBITOL (UNII: 506T60A25R)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

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: Yyba Corp
Labeler Code: 73581
FDA Application Number: part357B 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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 04-02-2021 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Pinrid 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

Active Ingredient

PYRANTEL PAMOATE 720.5 MG

Purpose

PINROOM TREATMENT

Use

FOR THE TREATMENT OF PINWORMS

Warnings

  • IF ANY OF THESE CONDITIONS PERSIST, CONSULT A DOCTORDIZZINESSDIARHEAABDOMINAL CRAMPSVOMITINGNAUSEAHEADACHEIF PREGNANT OR IF YOU HAVE LIVER DISEASE, ASK A DOCTOR BEFORE USE. CONSULT YOUR DOCTOR IF AN ALLERGIC REACTION OCCURS.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Other Information

  • PHENYLKETONURICS: CONTAIN PHENYLALANINE 11.8 MG PER TABLETREAD PACKAGE INSERT CAREFULLY BEFORE USINGIF SIGNS OF PINWORMS PERSIST, SEE A DOCTORSTORE AT 15° - 30°c (59° - 86°f)

Inactive Ingredients

Aspartame powder, citric acid, colloidal silicon dioxide, croscarmellose sodium, dextrose, FD&C yellow, magnesium stearate, maltodextrin, sorbitol, stearic acid, orange fl avor.

* Please review the disclaimer below.