Neomycin Sulfate

Product NDC
39822-0310
11-digit product format
398220310
Labeler code
39822
Product ID
39822-0310_d810b504-2761-e94f-e053-2a95a90ae498
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
XGen Pharmaceuticals DJB, Inc.
Application
ANDA065220
Marketing category
ANDA
Marketing start
2010-03-12
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE
Active strength
500 mg/1
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-0310-5EA - Each39822-03102f55a80c-1254-46c9-ac72-473510d1fb2112012-07-24
39822-0310-7EA - Each39822-031030818f52-db21-4034-9c9f-6d978ea2583312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693NEOMYCIN SULFATE TABLET [X-GEN PHARMACEUTICALS, INC.]7
NEOMYCINACTIVE MOIETYI16QD7X297NEOMYCIN SULFATE TABLET [X-GEN PHARMACEUTICALS, INC.]7
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LNEOMYCIN SULFATE TABLET [X-GEN PHARMACEUTICALS, INC.]7
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQNEOMYCIN SULFATE TABLET [X-GEN PHARMACEUTICALS, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39822-0310NEOMYCIN SULFATE TABLET [XGEN PHARMACEUTICALS DJB, INC.]12Legacy NDC20240529_a35a558c-7d96-43fb-917b-475189772edd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39822-0310-539822031005100 BLISTER PACK in 1 BOX, UNIT-DOSE (39822-0310-5) > 1 TABLET in 1 BLISTER PACK (39822-0310-7) 100 blister pack2010-03-120000-00-00NoNoCurrent