Neomycin and Polymyxin B Sulfates and Dexamethasone

Product NDC
68788-7686
11-digit product format
687887686
Labeler code
68788
Product ID
68788-7686_d6762918-e534-4e2a-86fa-c543ec257274
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
neomycin sulfate, polymyxin b sulfate and dexamethasone
Dosage form
SUSPENSION
Route
OPHTHALMIC
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA062341
Marketing category
ANDA
Marketing start
2020-04-01
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE
Active strength
4 mg/mL; [USP'U]/mL; mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7686-5ML - Milliliter68788-768609d11c3f-33f5-45d5-a693-e240a47febc912020-07-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7686-5687887686055 mL in 1 BOTTLE, PLASTIC (68788-7686-5) 5 ml2020-04-010000-00-00NoNoCurrent