FDA.reportPublic FDA data

Neomycin and Polymyxin B Sulfates

Product NDC
39822-1220
11-digit product format
398221220
Labeler code
39822
Product ID
39822-1220_4d508cf6-f6a4-be9f-e063-6394a90af91e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin and Polymyxin B Sulfates
Dosage form
SOLUTION
Route
IRRIGATION
Labeler
XGen Pharmaceuticals DJB, Inc.
Application
ANDA065108
Marketing category
ANDA
Marketing start
2006-01-31
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
40; 200000 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOMYCIN SULFATE40 mg/mL
POLYMYXIN B SULFATE200000 [USP'U]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19371312D4, 057Y626693
Rxcui314124

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39822-1220-1Neomycin and Polymyxin B Sulfates1 in 1 CARTONSOLUTION118
39822-1220-1Neomycin and Polymyxin B Sulfates20 mL in 1 VIAL, GLASSSOLUTION2018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-1220-1ML - Milliliter39822-1220d40b9716-4fbd-44a3-a3ab-14d50d63e10b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION [X-GEN PHARMACEUTICALS, INC.]6
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION [X-GEN PHARMACEUTICALS, INC.]6
NEOMYCINACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION [X-GEN PHARMACEUTICALS, INC.]6
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES SOLUTION [X-GEN PHARMACEUTICALS, INC.]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNEOMYCIN AND POLYMYXIN B SULFATES SOLUTION [X-GEN PHARMACEUTICALS, INC.]6
NITROGENINACTIVE INGREDIENTN762921K75NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION [X-GEN PHARMACEUTICALS, INC.]6
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFNEOMYCIN AND POLYMYXIN B SULFATES SOLUTION [X-GEN PHARMACEUTICALS, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RNEOMYCIN AND POLYMYXIN B SULFATES SOLUTION [X-GEN PHARMACEUTICALS, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39822-1220NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION [XGEN PHARMACEUTICALS DJB, INC.]16Current NDC, Legacy NDC, 2 package rows20231219_a2f47d77-efd3-4c84-a364-08fb6d9978eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314124neomycin sulfate 40 MG / polymyxin B sulfate 200,000 UNT per mL Irrigation SolutionPSNa2f47d77-efd3-4c84-a364-08fb6d9978eb18
314124neomycin 40 MG/ML / polymyxin B 200000 UNT/ML Irrigation SolutionSCDa2f47d77-efd3-4c84-a364-08fb6d9978eb18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
39822-1220-1398221220011 VIAL, GLASS in 1 CARTON (39822-1220-1) / 20 mL in 1 VIAL, GLASS2006-01-310000-00-00NoNoCurrent