FDA.reportPublic FDA data

BACITRACIN ZINC AND POLYMYXIN B SULFATE

Product NDC
72189-017
11-digit product format
721890017
Labeler code
72189
Product ID
72189-017_8e6c9fb6-c8dc-20db-e053-2a95a90a3a86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACITRACIN ZINC AND POLYMYXIN B SULFATE
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Direct_Rx
Application
ANDA064046
Marketing category
ANDA
Marketing start
2019-07-24
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
2020-12-31
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
72189-017-352023-01-30C16284748780-1f386c649-e07e-0266-e053-dadaa90a7c1aBACITRACIN ZINC AND POLYMYXIN B SULFATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-017-35BACITRACIN ZINC AND POLYMYXIN B SULFATE3.5 g in 1 BOTTLEOINTMENT3.51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-017-35GM - Gram72189-017ce456f34-cb5f-4595-9140-39b81438a87712019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-017BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [DIRECT_RX]1Legacy NDC, 1 package rows20190802_8e6c9fb6-c8db-20db-e053-2a95a90a3a86.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 OintmentPSN8e6c9fb6-c8db-20db-e053-2a95a90a3a861
308511bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD8e6c9fb6-c8db-20db-e053-2a95a90a3a861
308511bacitracin (as bacitracin zinc) 500 UNT / polymyxin B (as polymyxin B sulfate) 10,000 UNT per GM Ophthalmic OintmentSY8e6c9fb6-c8db-20db-e053-2a95a90a3a861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-017-35721890017353.5 g in 1 BOTTLE (72189-017-35) 3.5 g2019-07-240000-00-00NoNoCurrent