FDA.reportPublic FDA data

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN

Product NDC
50090-0247
11-digit product format
500900247
Labeler code
50090
Product ID
50090-0247_2df71383-cdc7-4f27-bf66-4cd1cef9f8a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
neomycin sulfate, polymyxin b sulfate and gramicidin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA064047
Marketing category
ANDA
Marketing start
1996-01-31
Substance
GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
.025; 1.75; 10000 mg/mL; mg/mL; [USP'U]/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], 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
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GRAMICIDIN.025 mg/mL
NEOMYCIN SULFATE1.75 mg/mL
POLYMYXIN B SULFATE10000 [USP'U]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5IE62321P4, 057Y626693, 19371312D4
Rxcui310594

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0247-02023-02-07C16284748780-1f386c649-a206-0266-e053-dadaa90a7c1aNeomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution, USP
50090-0247-02023-01-30C16284748780-1f386c649-a206-0266-e053-dadaa90a7c1aNeomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0247-0NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN1 in 1 CARTONSOLUTION/ DROPS120
50090-0247-0NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0247-0ML - Milliliter50090-02479d6acf78-e858-4fab-ba17-a6c659d8d64812018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0247NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]18Current NDC, Legacy NDC, 2 package rows20230208_9691178e-5323-40ce-a8b3-f79e88f02797.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310594gramicidin 0.025 MG / neomycin sulfate 1.75 MG / polymyxin B sulfate 10,000 UNT per ML Ophthalmic SolutionPSN9691178e-5323-40ce-a8b3-f79e88f0279720
310594gramicidin 0.025 MG/ML / neomycin 1.75 MG/ML / polymyxin B 10000 UNT/ML Ophthalmic SolutionSCD9691178e-5323-40ce-a8b3-f79e88f0279720
310594gramicidin 0.025 MG / neomycin (as neomycin sulfate) 1.75 MG / polymyxin B (as polymyxin B sulfate) 10,000 UNT per ML Ophthalmic SolutionSY9691178e-5323-40ce-a8b3-f79e88f0279720

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0247-0500900247001 BOTTLE, DROPPER in 1 CARTON (50090-0247-0) / 10 mL in 1 BOTTLE, DROPPER2016-06-290000-00-00NoNoCurrent