Home NDC 57319-347 Neomycin Polymyxin B Sulfates and Dexamethasone
Product NDC 57319-347
11-digit product format 573190347
Labeler code 57319
Product ID 57319-347_61b2cb3a-9512-48a0-a01d-2cacebeae7fe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Phoenix Pharmaceutical, Inc.
Application ANDA064135
Marketing category ANDA
Marketing start 1995-09-13
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 E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57319-347-01 Neomycin Polymyxin B Sulfates and Dexamethasone 1 in 1 CARTON SUSPENSION/ DROPS 1 1 57319-347-01 Neomycin Polymyxin B Sulfates and Dexamethasone 5 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 5 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Dexamethasone ACTIVE INGREDIENT 7S5I7G3JQL NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PHOENIX PHARMACEUTICAL, INC.] 1 Neomycin Sulfate ACTIVE INGREDIENT 057Y626693 NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PHOENIX PHARMACEUTICAL, INC.] 1 Polymyxin B Sulfate ACTIVE INGREDIENT 19371312D4 NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PHOENIX PHARMACEUTICAL, INC.] 1 DEXAMETHASONE ACTIVE MOIETY 7S5I7G3JQL NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PHOENIX PHARMACEUTICAL, INC.] 1 NEOMYCIN ACTIVE MOIETY I16QD7X297 NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PHOENIX PHARMACEUTICAL, INC.] 1 POLYMYXIN B ACTIVE MOIETY J2VZ07J96K NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PHOENIX PHARMACEUTICAL, INC.] 1 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PHOENIX PHARMACEUTICAL, INC.] 1 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PHOENIX PHARMACEUTICAL, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PHOENIX PHARMACEUTICAL, INC.] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PHOENIX PHARMACEUTICAL, INC.] 1 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PHOENIX PHARMACEUTICAL, INC.] 1 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PHOENIX PHARMACEUTICAL, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PHOENIX PHARMACEUTICAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57319-347 NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PHOENIX PHARMACEUTICAL, INC.] 1 Legacy NDC, 2 package rows 20101203_61b2cb3a-9512-48a0-a01d-2cacebeae7fe.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 57319-347-01 57319034701 1 in 1 CARTON Historical