Bacitracin Zinc and Polymyxin B Sulfate

Product NDC
0168-0273
11-digit product format
001680273
Labeler code
0168
Product ID
0168-0273_e16cc886-1989-4220-85ae-6b0cc2e3dee4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bacitracin Zinc and Polymyxin B Sulfate
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
E. FOUGERA & CO., A division of Nycomed US Inc.
Application
ANDA065022
Marketing category
ANDA
Marketing start
2008-08-28
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength
500 1/g; 1/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0273-382020-01-31C16284748780-19d75b9d0-0574-f424-e053-dadaa90a57ceBACITRACIN ZINC AND POLYMYXIN B SULFATE OPHTHALMIC OINTMENT, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0168-0273-38Bacitracin Zinc and Polymyxin B Sulfate3.5 g in 1 TUBEOINTMENT3.54

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0273BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [E. FOUGERA & CO., A DIVISION OF NYCOMED US INC.]4Legacy NDC, 1 package rows20090923_58f12018-ef71-4a2b-a6f5-6ec3ac19c353.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308511bacitracin zinc 500 UNT / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSN58f12018-ef71-4a2b-a6f5-6ec3ac19c3534
308511bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD58f12018-ef71-4a2b-a6f5-6ec3ac19c3534
308511bacitracin (as bacitracin zinc) 500 UNT / polymyxin B (as polymyxin B sulfate) 10,000 UNT per GM Ophthalmic OintmentSY58f12018-ef71-4a2b-a6f5-6ec3ac19c3534

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0168-0273-38001680273383.5 g in 1 TUBE3.5 gHistorical