Neomycin And Polymyxin B Sulfates And Hydrocortisone Suspension/ Drops
NDC Package 63187-308-10
Package Information
Neomycin And Polymyxin B Sulfates And Hydrocortisone (neomycin sulfate, polymyxin b sulfate and hydrocortisone) suspension/ dropses is a medication contraindicated in those individuals who have shown hypersensitivity to any of its components, and in herpes simplex, vaccinia, and varicella infections. This formulation utilizes a suspension/ drops delivery system. Marketed by Proficient Rx Lp, this product is identified by NDC 63187-308 and is authorized under FDA application ANDA064065.
Identification & Billing
- RxCUI: 310687 - hydrocortisone 10 MG (1 % ) / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per mL Otic Suspension
- RxCUI: 310687 - hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic Suspension
- RxCUI: 310687 - hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per 1 ML Otic Suspension
Clinical Specifications
- Aminoglycoside Antibacterial - [EPC] (Established Pharmacologic Class)
- Aminoglycosides - [CS]
- Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
- Corticosteroid - [EPC] (Established Pharmacologic Class)
- Polymyxin-class Antibacterial - [EPC] (Established Pharmacologic Class)
- Polymyxins - [CS]
Regulatory & Marketing
Hierarchy Structure
- 63187 - Proficient Rx Lp
- 63187-308 - Neomycin And Polymyxin B Sulfates And Hydrocortisone
- 63187-308-10 - 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER
- 63187-308 - Neomycin And Polymyxin B Sulfates And Hydrocortisone
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 63187-308-10 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper of Neomycin And Polymyxin B Sulfates And Hydrocortisone, a human prescription drug labeled by Proficient Rx Lp. This suspension/ drops is formulated for auricular (otic) use and contains hydrocortisone; neomycin sulfate; polymyxin b sulfate as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Proficient Rx Lp on August 28, 1996. The current certification is valid through December 31, 2026.
How is this Proficient Rx Lp product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 63187030810. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.