Bacitracin Zinc and Polymyxin B Sulfate

Product NDC
53002-9271
11-digit product format
530029271
Labeler code
53002
Product ID
53002-9271_91debbec-3740-4743-80a6-6ba5009411ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bacitracin Zinc and Polymyxin B Sulfate
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA064046
Marketing category
ANDA
Marketing start
2008-04-25
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength
500 [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
2021-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-9271-1Bacitracin Zinc and Polymyxin B Sulfate3.5 g in 1 BOTTLE, DROPPEROINTMENT3.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-9271BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 1 package rows20230609_51c5b733-ee9d-4f34-bdc6-38c837e0dee8.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 OintmentPSN51c5b733-ee9d-4f34-bdc6-38c837e0dee83
308511bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD51c5b733-ee9d-4f34-bdc6-38c837e0dee83
308511bacitracin (as bacitracin zinc) 500 UNT / polymyxin B (as polymyxin B sulfate) 10,000 UNT per GM Ophthalmic OintmentSY51c5b733-ee9d-4f34-bdc6-38c837e0dee83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-9271-1530029271013.5 g in 1 BOTTLE, DROPPER (53002-9271-1) 3.5 g2019-06-010000-00-00NoNoCurrent