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Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin Sulfate, 3.5 mg/g; 10000 [USP'U]/g; 1 mg/g Ointment, 1 tube — NDC 63187-669-35 (Billing 63187-0669-35)

by Proficient Rx LP · 1 TUBE in 1 CARTON / 3.5 g in 1 TUBE

This is a package of 1 tube of Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin Sulfate, 3.5 mg/g; 10000 [USP'U]/g; 1 mg/g Ointment from Proficient Rx LP, marketed since Jul 1994 and currently FDA-listed. It is this product's only package size.

NDC 63187-0669-35
🏷️ FDA NDC (as labeled) 63187-669-35 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63187-669-35
Product NDC 63187-669
11-digit billing NDC 63187066935
RxCUI 309679
UNII 057Y626693, 19371312D4, 7S5I7G3JQL
UPC 0363187669355
Application # ANDA064063
SPL Set ID 21c9b34c-af88-4c9e-9b6c-32d78d34ba7e
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1994-07-25
Route OPHTHALMIC
Dosage form OINTMENT
Substance NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE
TE code (Orange Book) AT · RLD · RS
Quick answers
  • RxCUI (RxNorm): 309679
Why two NDCs? The FDA registers this code as 63187-669-35 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63187-0669-35. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids for local oral treatment, Corticosteroids, Corticosteroids, moderately potent (group II)
How it works Corticosteroid Hormone Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It treats inflamed eyes when there is a bacterial infection or a risk of one. That includes inflammation of the conjunctiva, cornea and front of the eye, chronic anterior uveitis,...
  • Tilt your head back and pull your lower lid down to make a small pocket. Place about a half inch of ointment there without letting the tube touch your eye. Then look down before cl...
  • Some labels say to shake the suspension well before using it, so check yours. The drops go in the eye only, and the amount and frequency depend on how severe your condition is. Fol...
  • You may notice redness, irritation, or itching if you are allergic to the antibiotic. Steroids can also raise eye pressure and slow healing. Call your doctor if you have eye pain,...
📖 Read our full Dexamethasone / Neomycin / Polymyxin B guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $3.50 $12.27 / 3.5 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63187-0669-35 You're viewing this Main listing 1 TUBE in 1 CARTON / 3.5 g in 1 TUBE 2018-12-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Neomycin and Polymyxin B Sulfates and Dexamethasone 3.5 mg/g; 10000 [USP'U]/g; 1 mg/g 24208-0795-35 Bausch 1 tube $2.551 AT Availability likely —
Neomycin and Polymyxin B Sulfates and Dexamethasone 3.5 mg/g; 10000 [iU]/g; 1 mg/g 61314-0631-36 Sandoz 3.5 g $2.551 AT Availability likely —
Maxitrol 3.5 mg/g; 10000 [USP'U]/g; 1 mg/g 00078-0771-01 Novartis 3.5 g — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Dexamethasone 3.5 mg/g; 10000 [iU]/g; 1 mg/g 50090-4435-00 A-S 3.5 g — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Dexamethasone 3.5 mg/g; 10000 [USP'U]/g; 1 mg/g 50090-6181-00 A-S 1 tube — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Dexamethasone 1 mg/g; 3.5 mg/g; 10000 [USP'U]/g 63187-0395-35 Proficient 1 tube — — FDA listed —
Neomycin and Polymyxin B Sulfates and Dexamethasone 3.5 mg/g; 10000 [USP'U]/g; 1 mg/gthis 63187-0669-35 Proficient 1 tube — AT FDA listed —
Maxitrol 3.5 mg/g; 10000 [USP'U]/g; 1 mg/g 66758-0070-38 Sandoz 3.5 g — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Dexamethasone 3.5 mg/g; 10000 [USP'U]/g; 1 mg/g 68071-2428-03 NuCare 1 tube — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Dexamethasone 3.5 mg/g; 10000 [iU]/g; 1 mg/g 68071-5281-03 NuCare 3.5 g — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Dexamethasone 3.5 mg/g; 10000 [USP'U]/g; 1 mg/g 68788-8748-03 Preferred 1 tube — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Dexamethasone 3.5 mg/g; 10000 [iU]/g; 1 mg/g 71205-0330-35 Proficient 3.5 g — AT FDA listed —
Neo/Poly-B/Dex Ophth Oint 10000 [USP'U]/g; 3.5 mg/g; 1 mg/g 72189-0532-35 Direct_Rx 3.5 g — AT FDA listed —
Neomycin And Polymyxin B Sulfates And Dexamethasone 3.5 mg/g; 10000 [USP'U]/g; 1 mg/g 80425-0229-01 Advanced 1 tube — AT FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1994
On the market since
Jul 1994
📍
2026
Currently FDA-listed
32 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 7EV65EAW6H
    Lanolin is a waxy substance derived from sheep's wool. It's used in medicines as an emollient and skin-conditioning agent to soften formulations and improve spreadability in topical products like creams and ointments.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerProficient Rx LP
Application holderBAUSCH AND LOMB INC
FDA applicationANDA064063 (ANDA)
Labeler code63187
First marketedJul 1994
Product typeHuman Prescription Drug
Portfolio1,729 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 174 words ▾

INDICATIONS AND USAGE: For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain cases of infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical radiation or thermal burns; or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drugs in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species , Pseudomonas aeruginosa . This product does not provide adequate coverage against Serratia marcescens, and Streptococci, including Streptococcus pneumoniae .

⏱️ Dosage and Administration 144 words ▾

DOSAGE AND ADMINISTRATION: Apply a small amount into the conjunctival sac(s) up to three or four times daily, or may be used adjunctively with Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension at bedtime. How to apply Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment: 1. Tilt your head back.

2. Place a finger on your cheek just under your eye and gently pull down until a "V" pocket is formed between your eyeball and your lower lid. 3.

Place a small amount (about 1/2 inch) of Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment in the "V" pocket. Do not let the tip of the tube touch your eye. 4.

Look downward before closing your eye. Not more than 8 grams should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

⛔ Contraindications 50 words ▾

CONTRAINDICATIONS: Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication. (Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.)

⚠️ Warnings 144 words ▾

WARNINGS: NOT FOR INJECTION. Do not touch tube tip to any surface, as this may contaminate the contents. Prolonged use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.

Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.

If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Products containing neomycin sulfate may cause cutaneous sensitization. Employment of steroid medication in the treatment of herpes simplex requires great caution.

🤒 Adverse Reactions 146 words ▾

ADVERSE REACTIONS: Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available. Reactions occurring most often from the presence of the anti-infective ingredients are allergic sensitizations.

The reactions due to the steroid component are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. Secondary Infection: The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids.

The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.

🤰 Pregnancy 117 words ▾

Pregnancy: Pregnancy Category C. Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose. In the mouse, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate.

In the rabbit, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc. There are no adequate or well-controlled studies in pregnant women. Neomycin, Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.

Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.

🧒 Pediatric Use 12 words ▾

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

🧬 Clinical Pharmacology 135 words ▾

CLINICAL PHARMACOLOGY: Corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow the healing. Since corticoids may inhibit the body's defense mechanism against infections, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case. When a decision to administer both a corticoid and an antimicrobial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered, plus assured compatibility of ingredients when both types of drugs are in the same formulation and, particularly, that the correct volume of drug is delivered and retained.

The relative potency of corticosteroids depends on the molecular structure, concentration, and release from the vehicle.

📦 How Supplied / Storage and Handling 82 words ▾

HOW SUPPLIED: Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment USP is supplied in an ophthalmic tube in the following size: 3.5 gram tube – NDC 63187-669-35 Storage: Store between 15°-25° C (59°-77° F). KEEP OUT OF REACH OF CHILDREN. DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.

FOR OPHTHALMIC USE ONLY. Revised November 2007 Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 9114002 (Folded) 9114102 (Flat)

📦 Storage and Handling 54 words ▾

Storage: Store between 15°-25° C (59°-77° F). KEEP OUT OF REACH OF CHILDREN. DO NOT USE IF CAP AND NECKRING ARE NOT INTACT. FOR OPHTHALMIC USE ONLY. Revised November 2007 Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 9114002 (Folded) 9114102 (Flat)

📋 Description 197 words ▾

DESCRIPTION: Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment USP is a multiple dose anti-infective steroid combination in a sterile ointment for topical application. The active ingredient dexamethasone, is represented by the following structural formula: C 22 H 29 FO 5 Mol. Wt.

392.47 Chemical Name: Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11β,16α)-. Neomycin Sulfate is the sulfate salt of neomycin B and C which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae).

It has a potency equivalent to not less than 600 micrograms of neomycin base per milligram, calculated on an anhydrous basis. The structural formulae are: Polymyxin B Sulfate is the sulfate salt of polymyxin B 1 and B 2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae).

It has a potency of not less than 6,000 polymyxin B units per milligram, calculated on an anhydrous basis. The structural formulae are: Each Gram Contains: ACTIVES: Neomycin Sulfate (equivalent to 3.5 mg Neomycin), Polymyxin B Sulfate, equal to 10,000 polymyxin B units; Dexamethasone 1 mg (0.1%). INACTIVES: White Petrolatum, Lanolin, Mineral Oil.

PRESERVATIVES ADDED: Methylparaben 0.05%, Propylparaben 0.01%. Neomycin Sulfate (structural formula) Neomycin Sulfate (structural formula) Polymyxin B Sulfate (structural formula)

💬 Information for Patients 17 words ▾

Information for Patients: Do not touch tube tip to any surface, as this may contaminate the contents.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 63187-0667-30 · Proficient 63187-0670-10 · Proficient →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.