Sion Biotext Bacitracin Zinc

Product NDC
68786-500
11-digit product format
687860500
Labeler code
68786
Product ID
68786-500_376a6fcb-77cd-e812-e063-6294a90ac39c
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sion Biotext Medical Ltd
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-13
Substance
BACITRACIN ZINC
Active strength
500 [iU]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sion Biotext Bacitracin Zinc
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [iU]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES
Rxcui1366116

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68786-500-01Sion Biotext Bacitracin Zinc28 g in 1 TUBEOINTMENT282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68786-500SION BIOTEXT BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [SION BIOTEXT MEDICAL LTD]1Current NDC, 1 package rows20250515_35056345-f325-99e8-e063-6294a90a2d7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN35056345-f325-99e8-e063-6294a90a2d7e2
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD35056345-f325-99e8-e063-6294a90a2d7e2
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY35056345-f325-99e8-e063-6294a90a2d7e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68786-500-016878605000128 g in 1 TUBE (68786-500-01) 28 g2025-05-13NoNoHistorical