Neomycin and Polymyxin B Sulfates and Dexamethasone

Product NDC
13985-744
11-digit product format
139850744
Labeler code
13985
Product ID
13985-744_d178cf8f-5bce-43f8-b436-cd963b428bee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
MWI
Application
ANDA064063
Marketing category
ANDA
Marketing start
1994-07-25
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE
Active strength
4 mg/g; [USP'U]/g; mg/g
Pharmacologic classes
Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13985-744-352025-12-29C16284748780-1d6a99b39-4e3c-a426-e053-dadaa90af4c23cd3c3bd-9214-4ded-838d-1bc0ff9adc61
13985-744-352022-01-28C16284748780-1d6a99b39-4e3c-a426-e053-dadaa90af4c23cd3c3bd-9214-4ded-838d-1bc0ff9adc61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13985-744NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE) OINTMENT [MWI]2Legacy NDC20170327_3cd3c3bd-9214-4ded-838d-1bc0ff9adc61.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13985-744-35139850744351 TUBE in 1 CARTON (13985-744-35) > 3.5 g in 1 TUBE1 tube1994-07-250000-00-00NoNoCurrent