Home NDC 68788-9702 Neomycin Polymyxin B Sulfates and Dexamethasone
Product NDC 68788-9702
11-digit product format 687889702
Labeler code 68788
Product ID 68788-9702_e445f9fe-3091-4ff5-af8a-9be502efd245
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Preferred Pharmaceuticals, Inc.
Application ANDA064135
Marketing category ANDA
Marketing start 2013-03-14
Substance DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength 1; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Neomycin Polymyxin B Sulfates and Dexamethasone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXAMETHASONE 1 mg/mL NEOMYCIN SULFATE 3.5 mg/mL POLYMYXIN B SULFATE 10000 [USP'U]/mL
Harmonized Identifiers# Field, Values table Field Values Unii 7S5I7G3JQL, 057Y626693, 19371312D4 Rxcui 309680
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68788-9702-5 Neomycin Polymyxin B Sulfates and Dexamethasone 5 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 5 13 68788-9702-5 Neomycin Polymyxin B Sulfates and Dexamethasone 1 in 1 CARTON SUSPENSION/ DROPS 1 13
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 [PREFERRED PHARMACEUTICALS, INC.] 2 NEOMYCIN SULFATE ACTIVE INGREDIENT 057Y626693 NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2 POLYMYXIN B SULFATE ACTIVE INGREDIENT 19371312D4 NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2 DEXAMETHASONE ACTIVE MOIETY 7S5I7G3JQL NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2 NEOMYCIN ACTIVE MOIETY I16QD7X297 NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2 POLYMYXIN B ACTIVE MOIETY J2VZ07J96K NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-9702 NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [PREFERRED PHARMACEUTICALS, INC.] 12 Current NDC, Legacy NDC, 2 package rows 20240724_449a6fd8-c2ac-40d0-b74a-e5c7fc6670f3.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68788-9702-5 68788970205 1 BOTTLE, DROPPER in 1 CARTON (68788-9702-5) / 5 mL in 1 BOTTLE, DROPPER 2013-03-14 0000-00-00 No No Current