FDA.reportPublic FDA data

Leader Poly Bacitracin

Product NDC
70000-0694
11-digit product format
700000694
Labeler code
70000
Product ID
70000-0694_20d75f8e-2a81-2653-e063-6394a90a88a4
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc Polymixin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cardinal Health 110 dba LEADER
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-15
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength
500; 10000 [USP'U]/g; [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Leader Poly Bacitracin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [USP'U]/g
POLYMYXIN B SULFATE10000 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 19371312D4
Rxcui308512

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0694-1Leader Poly Bacitracin1 in 1 BOXOINTMENT11
70000-0694-1Leader Poly Bacitracin28 g in 1 TUBEOINTMENT281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0694LEADER POLY BACITRACIN (BACITRACIN ZINC POLYMIXIN B SULFATE) OINTMENT [CARDINAL HEALTH 110 DBA LEADER]1Current NDC, 2 package rows20240901_20d7624f-cafa-25e1-e063-6394a90a4439.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentPSN20d7624f-cafa-25e1-e063-6394a90a44391
308512bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical OintmentSCD20d7624f-cafa-25e1-e063-6394a90a44391
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentSY20d7624f-cafa-25e1-e063-6394a90a44391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0694-1700000694011 TUBE in 1 BOX (70000-0694-1) / 28 g in 1 TUBE1 tube2024-08-15NoNoCurrent