FDA.reportPublic FDA data

Bacitracin Zinc and Polymyxin B Sulfate

Product NDC
50090-7189
11-digit product format
500907189
Labeler code
50090
Product ID
50090-7189_325d8b12-136d-4848-96c5-46c8d0d2702c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bacitracin Zinc and Polymyxin B Sulfate
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bacitracin Zinc and Polymyxin B Sulfate
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7189-0Bacitracin Zinc and Polymyxin B Sulfate3.5 g in 1 TUBEOINTMENT3.54
50090-7189-0Bacitracin Zinc and Polymyxin B Sulfate144 in 1 CASEOINTMENT1444

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7189-0GM - Gram50090-71890aebd148-9720-4795-9c9c-07b29c41542912024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7189BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20240706_19b4cfab-5927-47c5-a032-58ab2998d9c7.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 OintmentPSN19b4cfab-5927-47c5-a032-58ab2998d9c74
308511bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD19b4cfab-5927-47c5-a032-58ab2998d9c74
308511bacitracin (as bacitracin zinc) 500 UNT / polymyxin B (as polymyxin B sulfate) 10,000 UNT per GM Ophthalmic OintmentSY19b4cfab-5927-47c5-a032-58ab2998d9c74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7189-050090718900144 TUBE in 1 CASE (50090-7189-0) / 3.5 g in 1 TUBE144 tube2024-07-02NoNoHistorical