neomycin and polymyxin b sulfates and dexamethasone

Generic: neomycin sulfate, polymyxin b sulfate, and dexamethasone

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name neomycin and polymyxin b sulfates and dexamethasone
Generic Name neomycin sulfate, polymyxin b sulfate, and dexamethasone
Labeler proficient rx lp
Dosage Form OINTMENT
Routes
OPHTHALMIC
Active Ingredients

dexamethasone 1 mg/g, neomycin sulfate 3.5 mg/g, polymyxin b sulfate 10000 [USP'U]/g

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-669
Product ID 63187-669_84f8a211-aaba-4d86-b71c-9a0632217c9e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064063
Listing Expiration 2026-12-31
Marketing Start 1994-07-25

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187669
Hyphenated Format 63187-669

Supplemental Identifiers

RxCUI
309679
UPC
0363187669355
UNII
7S5I7G3JQL 057Y626693 19371312D4
NUI
N0000175576 N0000175450

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 dexamethasone (source: ndc)
Generic Name neomycin sulfate, polymyxin b sulfate, and dexamethasone (source: ndc)
Application Number ANDA064063 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
  • 3.5 mg/g
  • 10000 [USP'U]/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (63187-669-35) / 3.5 g in 1 TUBE
source: ndc

Packages (1)

63187-669-35 1 TUBE in 1 CARTON (63187-669-35) / 3.5 g in 1 TUBE

Ingredients (3)

dexamethasone (1 mg/g) neomycin sulfate (3.5 mg/g) polymyxin b sulfate (10000 [USP'U]/g)

Linked Drug Pages (1)

Neomycin and Polymyxin B Sulfates and Dexamethasone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "84f8a211-aaba-4d86-b71c-9a0632217c9e", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0363187669355"], "unii": ["7S5I7G3JQL", "057Y626693", "19371312D4"], "rxcui": ["309679"], "spl_set_id": ["21c9b34c-af88-4c9e-9b6c-32d78d34ba7e"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (63187-669-35)  / 3.5 g in 1 TUBE", "package_ndc": "63187-669-35", "marketing_start_date": "20181201"}], "brand_name": "Neomycin and Polymyxin B Sulfates and Dexamethasone", "product_id": "63187-669_84f8a211-aaba-4d86-b71c-9a0632217c9e", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "63187-669", "generic_name": "Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Neomycin and Polymyxin B Sulfates and Dexamethasone", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "1 mg/g"}, {"name": "NEOMYCIN SULFATE", "strength": "3.5 mg/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "10000 [USP'U]/g"}], "application_number": "ANDA064063", "marketing_category": "ANDA", "marketing_start_date": "19940725", "listing_expiration_date": "20261231"}