BISACODYL

Product NDC
68784-102
Requested package NDC
68784-102-12
11-digit product format
687840102
Labeler code
68784
Product ID
68784-102_c29c6c3c-e5cf-2f94-e053-2a95a90a1b41
Type
HUMAN OTC DRUG
Nonproprietary name
BISACODYL
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Acino Products, LLC
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2005-01-01
Marketing end
0000-00-00
Substance
BISACODYL
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68784-10268784-102-12IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68784-10268784-102-12IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage68784-10268784-102-12EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68784-102-12EA - Each68784-102cbea6d32-e10f-4c6f-b3d4-c3d868f7cb1d12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6IBISACODYL SUPPOSITORY [ACINO PRODUCTS, LLC]1
BISACODYLACTIVE MOIETY10X0709Y6IBISACODYL SUPPOSITORY [ACINO PRODUCTS, LLC]1
FAT, HARDINACTIVE INGREDIENT8334LX7S21BISACODYL SUPPOSITORY [ACINO PRODUCTS, LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68784-102-126878401021212 BLISTER PACK in 1 BOX (68784-102-12) > 1 SUPPOSITORY in 1 BLISTER PACK12 blister pack2021-05-180000-00-00NoNoCurrent