FDA.reportPublic FDA data

Bacitracin Zinc and Polymyxin B Sulfate

Product NDC
68071-5267
11-digit product format
680715267
Labeler code
68071
Product ID
68071-5267_2a849ae9-3395-4642-e063-6394a90a1ca4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bacitracin Zinc and Polymyxin B Sulfate
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA064046
Marketing category
ANDA
Marketing start
2008-04-25
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
Bacitracin Zinc and Polymyxin B Sulfate
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
Rxcui308511

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
68071-5267-32022-02-07C16284748780-1d6a99b39-73d6-a426-e053-dadaa90af4c2Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP ( Sterile )
68071-5267-32022-01-28C16284748780-1d6a99b39-73d6-a426-e053-dadaa90af4c2Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP ( Sterile )

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5267-3Bacitracin Zinc and Polymyxin B Sulfate3.5 g in 1 BOXOINTMENT3.56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5267BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 1 package rows20250101_a73654f4-949d-3da4-e053-2995a90a1fc3.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 OintmentPSNa73654f4-949d-3da4-e053-2995a90a1fc36
308511bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCDa73654f4-949d-3da4-e053-2995a90a1fc36
308511bacitracin (as bacitracin zinc) 500 UNT / polymyxin B (as polymyxin B sulfate) 10,000 UNT per GM Ophthalmic OintmentSYa73654f4-949d-3da4-e053-2995a90a1fc36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5267-3680715267033.5 g in 1 BOX (68071-5267-3) 3.5 g2020-06-030000-00-00NoNoCurrent