FDA.reportPublic FDA data

BISAC-EVAC

Product NDC
0713-0109
Requested package NDC
0713-0109-05
11-digit product format
007130109
Labeler code
0713
Product ID
0713-0109_2d0b2d98-adf1-464a-96f4-7bb26a04dd29
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1991-05-22
Marketing end
0000-00-00
Substance
BISACODYL
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0713-01090713-0109-05DDiscontinued by firm2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0109-01EA - Each0713-0109a24d5b04-b98b-4320-8d58-8798644e4c6412013-02-13
0713-0109-05EA - Each0713-0109b9916a49-a99b-4e13-b96f-00267cb6cce612013-02-13
0713-0109-08EA - Each0713-0109c90b775d-b3c4-47da-9b24-25a33c01a71412013-02-13
0713-0109-10EA - Each0713-01096baa5398-e764-4939-af4e-7aea56d7450a12013-02-13
0713-0109-12EA - Each0713-01096af07ebf-ab99-4469-b0b1-e6dfaa2b405a12013-02-13
0713-0109-50EA - Each0713-01095351c6f4-b000-44da-bf60-2ce5dda6e1a912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6IBISAC-EVAC (BISACODYL) SUPPOSITORY [CARDINAL HEALTH]5
BISACODYLACTIVE MOIETY10X0709Y6IBISAC-EVAC (BISACODYL) SUPPOSITORY [CARDINAL HEALTH]5
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYBISAC-EVAC (BISACODYL) SUPPOSITORY [CARDINAL HEALTH]5
BisacodylACTIVE INGREDIENT10X0709Y6IBISAC-EVAC (BISACODYL) SUPPOSITORY [G&W LABORATORIES, INC.]1
BisacodylACTIVE MOIETY10X0709Y6IBISAC-EVAC (BISACODYL) SUPPOSITORY [G&W LABORATORIES, INC.]1
Hydrogenated Palm Kernel OilINACTIVE INGREDIENTFM8D1RE2VPBISAC-EVAC (BISACODYL) SUPPOSITORY [G&W LABORATORIES, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0109-0500713010905500 SUPPOSITORY in 1 CARTON (0713-0109-05) 500 suppository1991-05-220000-00-00NoNoCurrent