neomycin and polymyxin b sulfates and gramicidin

Generic: neomycin sulfate, polymyxin b sulfate and gramicidin

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name neomycin and polymyxin b sulfates and gramicidin
Generic Name neomycin sulfate, polymyxin b sulfate and gramicidin
Labeler a-s medication solutions
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

gramicidin .025 mg/mL, neomycin sulfate 1.75 mg/mL, polymyxin b sulfate 10000 [USP'U]/mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-0247
Product ID 50090-0247_2df71383-cdc7-4f27-bf66-4cd1cef9f8a5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064047
Listing Expiration 2027-12-31
Marketing Start 1996-01-31

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs] polymyxin-class antibacterial [epc] polymyxins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500900247
Hyphenated Format 50090-0247

Supplemental Identifiers

RxCUI
310594
UNII
5IE62321P4 057Y626693 19371312D4

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name neomycin and polymyxin b sulfates and gramicidin (source: ndc)
Generic Name neomycin sulfate, polymyxin b sulfate and gramicidin (source: ndc)
Application Number ANDA064047 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .025 mg/mL
  • 1.75 mg/mL
  • 10000 [USP'U]/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (50090-0247-0) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

50090-0247-0 1 BOTTLE, DROPPER in 1 CARTON (50090-0247-0) / 10 mL in 1 BOTTLE, DROPPER

Ingredients (3)

gramicidin (.025 mg/mL) neomycin sulfate (1.75 mg/mL) polymyxin b sulfate (10000 [USP'U]/mL)

Linked Drug Pages (1)

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "2df71383-cdc7-4f27-bf66-4cd1cef9f8a5", "openfda": {"unii": ["5IE62321P4", "057Y626693", "19371312D4"], "rxcui": ["310594"], "spl_set_id": ["9691178e-5323-40ce-a8b3-f79e88f02797"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (50090-0247-0)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "50090-0247-0", "marketing_start_date": "20160629"}], "brand_name": "NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN", "product_id": "50090-0247_2df71383-cdc7-4f27-bf66-4cd1cef9f8a5", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "50090-0247", "generic_name": "neomycin sulfate, polymyxin b sulfate and gramicidin", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN", "active_ingredients": [{"name": "GRAMICIDIN", "strength": ".025 mg/mL"}, {"name": "NEOMYCIN SULFATE", "strength": "1.75 mg/mL"}, {"name": "POLYMYXIN B SULFATE", "strength": "10000 [USP'U]/mL"}], "application_number": "ANDA064047", "marketing_category": "ANDA", "marketing_start_date": "19960131", "listing_expiration_date": "20271231"}