FDA.reportPublic FDA data

Bacitracin Zinc and Polymyxin B Sulfate

Product NDC
50090-3274
11-digit product format
500903274
Labeler code
50090
Product ID
50090-3274_f616c4bc-ebe1-4cf6-a22b-8f44773bc0d1
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3274-02023-02-07C16284748780-1f386c649-f1c4-0266-e053-dadaa90a7c1aBacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP (Sterile) Rx only
50090-3274-02023-01-30C16284748780-1f386c649-f1c4-0266-e053-dadaa90a7c1aBacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP (Sterile) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3274-0Bacitracin Zinc and Polymyxin B Sulfate3.5 g in 1 TUBEOINTMENT3.516
50090-3274-0Bacitracin Zinc and Polymyxin B Sulfate1 in 1 CARTONOINTMENT116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3274-0GM - Gram50090-327435e74983-db66-424d-ac7b-dba78c16e85b12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3274BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 2 package rows20230725_51f6eac3-205e-4beb-8522-6ba2c593f350.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 OintmentPSN51f6eac3-205e-4beb-8522-6ba2c593f35016
308511bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD51f6eac3-205e-4beb-8522-6ba2c593f35016
308511bacitracin (as bacitracin zinc) 500 UNT / polymyxin B (as polymyxin B sulfate) 10,000 UNT per GM Ophthalmic OintmentSY51f6eac3-205e-4beb-8522-6ba2c593f35016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3274-0500903274001 TUBE in 1 CARTON (50090-3274-0) / 3.5 g in 1 TUBE1 tube2017-11-210000-00-00NoNoCurrent