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NDC 00574-7050-50 Bisacodyl 10 mg/1 Details

Bisacodyl 10 mg/1

Bisacodyl is a RECTAL SUPPOSITORY in the HUMAN OTC DRUG category. It is labeled and distributed by Padagis US LLC. The primary component is BISACODYL.

MedlinePlus Drug Summary

Rectal bisacodyl is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Bisacodyl is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.

Related Packages: 00574-7050-50
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bisacodyl Rectal

Product Information

NDC	00574-7050
Product ID	0574-7050_06214150-2221-462b-a0ac-5a5a8a257c13
Associated GPIs	46200010005205
GCN Sequence Number	002944
GCN Sequence Number Description	bisacodyl SUPP.RECT 10 MG RECTAL
HIC3	Q3S
HIC3 Description	LAXATIVES, LOCAL/RECTAL
GCN	08731
HICL Sequence Number	001301
HICL Sequence Number Description	BISACODYL
Brand/Generic	Generic
Proprietary Name	Bisacodyl
Proprietary Name Suffix	n/a
Non-Proprietary Name	bisacodyl
Product Type	HUMAN OTC DRUG
Dosage Form	SUPPOSITORY
Route	RECTAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	BISACODYL
Labeler Name	Padagis US LLC
Pharmaceutical Class	Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00574-7050-50 (00574705050)

Pricing Information
NDC Package Code	0574-7050-50
Billing NDC	00574705050
Package	50 BLISTER PACK in 1 CARTON (0574-7050-50) / 1 SUPPOSITORY in 1 BLISTER PACK
Marketing Start Date	1990-09-01
NDC Exclude Flag	N
Price Per Unit	0.29334
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	BISACODYL 10 MG SUPPOSITORY
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 7eada0fc-5f83-43da-a56f-b0f537298208 Details

Active ingredient (in each suppository)

Bisacodyl USP 10 mg

Purpose

Stimulant laxative

Use

•: for temporary relief of occasional constipation and irregularity
•: this product generally produces bowel movement in 15 minutes to 1 hour

Warnings

For rectal use only

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

Ask a doctor or pharmacist before use if you are

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

When using this product

it may cause stomach discomfort, faintness, rectal burning and milk cramps

Stop use and ask a doctor if

•: you have rectal bleeding or fail to have a bowel movement after use of a laxative because this may indicate a serious condition
•: you need to use a laxative for more than 1 week

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

adults and children 12 years of age and over	1 suppository in a single daily dose. Pull apart foil. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes.
children 6 to under 12 years of age	½ suppository in a single daily dose
children under 6 years of age	ask a doctor

Other information

•: store at 20-25°C (68-77°F)

Inactive ingredients

hydrogenated vegetable oil

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

NDC 0574-7050-12

Bisacodyl Suppositories, USP

10 mg

Stimulant Laxative

Easy-open plastic packets

Tapered shape for easy insertion

UNIT DOSE

12 Suppositories

INGREDIENTS AND APPEARANCE

BISACODYL

bisacodyl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0574-7050
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	10 mg

Ingredient Name	Strength
Inactive Ingredients
COTTONSEED OIL (UNII: H3E878020N)

Product Characteristics
Color	WHITE (white to cream)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0574-7050-12	12 in 1 CARTON	09/01/1990
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0574-7050-50	50 in 1 CARTON	09/01/1990
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	09/01/1990

Labeler - Padagis US LLC (967694121)

Revised: 11/2021

Document Id: 06214150-2221-462b-a0ac-5a5a8a257c13

Set id: 7eada0fc-5f83-43da-a56f-b0f537298208

Version: 4

Effective Time: 20211115