Neomycin Sulfate

Product NDC
62135-443
11-digit product format
621350443
Labeler code
62135
Product ID
62135-443_4bd236cf-36cb-c633-e063-6294a90a5b16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA204435
Marketing category
ANDA
Marketing start
2016-06-10
Substance
NEOMYCIN SULFATE
Active strength
500 mg/1
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [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 Sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOMYCIN SULFATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii057Y626693
Rxcui866042

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-443-90Neomycin Sulfate90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-443-90EA - Each62135-443532c4cae-6be9-41af-883f-0fbf7df11efd12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-443NEOMYCIN SULFATE TABLET [CHARTWELL RX, LLC]1Current NDC, 1 package rows20231206_0aa6947b-4739-4b00-be93-7303a5fc687d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866042neomycin sulfate 500 MG Oral TabletPSN0aa6947b-4739-4b00-be93-7303a5fc687d2
866042neomycin sulfate 500 MG Oral TabletSCD0aa6947b-4739-4b00-be93-7303a5fc687d2
866042neomycin sulfate 500 MG (neomycin 350 MG) Oral TabletSY0aa6947b-4739-4b00-be93-7303a5fc687d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-443-906213504439090 TABLET in 1 BOTTLE (62135-443-90) 90 tablet2023-11-27NoNoCurrent