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NDC 43749-0460-16 Avedana Gentle Laxative 10 mg/1 Details
Avedana Gentle Laxative 10 mg/1
Avedana Gentle Laxative is a RECTAL SUPPOSITORY in the HUMAN OTC DRUG category. It is labeled and distributed by Unipack 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: 43749-0460-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bisacodyl Rectal
Product Information
| NDC | 43749-0460 |
|---|---|
| Product ID | 43749-460_0e23b510-8245-a4c7-e063-6294a90a55b4 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Avedana Gentle Laxative |
| 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 | Unipack 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 DRUG |
| Application Number | M007 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 43749-0460-16 (43749046016)
| NDC Package Code | 43749-460-16 |
|---|---|
| Billing NDC | 43749046016 |
| Package | 4 BLISTER PACK in 1 CARTON (43749-460-16) / 4 SUPPOSITORY in 1 BLISTER PACK (43749-460-17) |
| Marketing Start Date | 2017-09-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |