NDC 68163-116 Bisacodyl Stimulant Laxative

Bisacodyl

NDC Product Code 68163-116

NDC CODE: 68163-116

Proprietary Name: Bisacodyl Stimulant Laxative 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: Bisacodyl 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Bisacodyl is used to treat constipation. It may also be used to clean out the intestines before a bowel examination/surgery. Bisacodyl is known as a stimulant laxative. It works by increasing the movement of the intestines, helping the stool to come out.

Product Characteristics

Color(s):
ORANGE (C48331)
Shape: ROUND (C48348)
Size(s):
6 MM
Imprint(s):
RP116
Score: 1

NDC Code Structure

  • 68163 - Raritan Pharmaceuticals Inc

NDC 68163-116-25

Package Description: 1 BLISTER PACK in 1 CARTON > 25 TABLET, COATED in 1 BLISTER PACK

NDC Product Information

Bisacodyl Stimulant Laxative with NDC 68163-116 is a a human over the counter drug product labeled by Raritan Pharmaceuticals Inc. The generic name of Bisacodyl Stimulant Laxative is bisacodyl. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Raritan Pharmaceuticals Inc

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

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.

Bisacodyl Stimulant Laxative 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.

  • BISACODYL 5 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.

  • ACACIA (UNII: 5C5403N26O)
  • CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • SHELLAC (UNII: 46N107B71O)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • RAW SUGAR (UNII: 8M707QY5GH)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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.
  • 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: Raritan Pharmaceuticals Inc
Labeler Code: 68163
FDA Application Number: part334 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 10-29-2019 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.

Bisacodyl Stimulant Laxative Product Label Images

Bisacodyl Stimulant Laxative 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 (In Each Tablet)

Bisacodyl, USP 5 mg

Purpose

Stimulant laxative

Use

  • ▪for relief of occasional constipation and irregularity▪this product generally produces a bowel movement in 6 to 12 hours

Do Not Use

If you cannot swallow without chewing.

Ask A Doctor Before Use If You Have

  • ▪stomach pain, nausea or vomiting▪a sudden change in bowel habits that lasts more than 2 weeks

When Using This Product

  • ▪it may cause stomach discomfort, faintness and cramps▪do not chew or crush tablet(s)▪do not use within 1 hour after taking an antacid or milk

Stop Use And Ask A Doctor If

  • ▪you have rectal bleeding or fail to have bowl movement after using this product. These could be signs of a serious condition.▪you need to use a laxative for more than 1 week

If Pregnancy Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

Take with a glass of wateradults and children 12 years of age and over  1 to 3 tablets in a single daily dose children 6 to under 12 years of age1 tablet in a single daily dosechildren under 6 years of ageask a doctor

Other Information

  • •store at room temperature •Protect from excessive humidity

Inactive Ingredients

Acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow No. 10, FD&C yellow No. 6, gelatin, iron oxide, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide.

* Please review the disclaimer below.