HomeNDC LookupIngredientsTobramycin › 62250-0110-01
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Tobramycin 3 mg/mL Solution/ Drops

by Belcher Pharmaceuticals, LLC · 1 BOTTLE, PLASTIC in 1 CARTON (62250-110-01) / 5 mL in 1 BOTTLE, PLASTIC
NDC 62250-0110-01
🏷️ FDA NDC (as labeled) 62250-110-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 62250-110-01
Product NDC 62250-110
11-digit billing NDC 62250011001
RxCUI 313415
UNII VZ8RRZ51VK
Application # ANDA212628
SPL Set ID 17b5b083-79ab-46b5-bed6-866e5415c623
Established class (EPC) Aminoglycoside Antibacterial
Chemical class Aminoglycosides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-04-01
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance TOBRAMYCIN
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 62250-110-01 — 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 → 62250-0110-01. 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 Aminoglycoside Antibacterial class.

Pharmacologic class Aminoglycoside Antibacterial
Drug family (ATC) Other aminoglycosides, Antibiotics
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.

🏭 Manufacturer & labeler

LabelerBelcher Pharmaceuticals, LLC
Application holderGLAND PHARMA LTD
FDA applicationANDA212628 (ANDA)
Labeler code62250
First marketedApr 2024
Product typeHuman Prescription Drug
Portfolio2 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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • That on-off cycle is how the inhaled tobramycin products are designed to work for cystic fibrosis. You use it for 28 days to reduce the Pseudomonas aeruginosa bacteria in your lung...
  • I have cystic fibrosis. Why is tobramycin given in a cycle of 28 days on and 28 days off?
  • No — TOBI Podhaler capsules must never be swallowed. They are specially designed to be inhaled using the Podhaler device, which delivers the medicine directly to your lungs where i...
  • Can I swallow the TOBI Podhaler capsules if I have trouble using the inhaler?
📖 Read our full Tobramycin guide →
8
Nutrient depletion considerations

Tobramycin may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

🧪 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 F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII R57ZHV85D4
    Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 0YPR65R21J
    Sodium sulfate is a mineral salt used in pharmaceuticals as a filler and diluent. It helps provide bulk and stability to tablets and capsules while remaining inert in the body.
  • UNII O40UQP6WCF
    A strong acid used in small amounts to adjust and maintain the pH balance of a medicine, helping ensure stability and proper dissolution of the active ingredients.
  • UNII Y27PUL9H56
    Tyloxapol is a synthetic detergent and surfactant used in medications as a solubilizer and emulsifier. It helps dissolve or blend ingredients that don't naturally mix well, improving how the medicine disperses in liquid formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

8 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 DailyMedingredient 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.

💲 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 mLPer 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 $0.9370 $4.69 / 5 ml
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tobramycin 3 mg/mL 24208-0290-05 Bausch 1 bottle $1.158 AT Availability likely
Tobramycin 3 mg/mL 61314-0643-05 Sandoz 5 ml $1.158 AT Availability likely
Tobramycin Ophthalmic Solution 3 mg/mL 62332-0518-05 Alembic 1 bottle $1.158 AT Availability likely
Tobramycin 3 mg/mL 70069-0131-01 Somerset 1 bottle $1.158 AT Availability likely
Tobramycin Ophthalmic Solution 3 mg/mL 46708-0518-05 Alembic 1 bottle AT FDA listed
Tobramycin 3 mg/mL 50090-2127-00 A-S 1 bottle AT FDA listed
Tobramycin 3 mg/mL 50090-4190-00 A-S 1 bottle AT FDA listed
Tobramycin 3 mg/mL 60760-0583-05 St. 1 bottle AT FDA listed
Tobramycin 3 mg/mL 61919-0642-05 DirectRX 5 ml AT FDA listed
Tobramycin 3 mg/mLthis 62250-0110-01 Belcher 1 bottle AT FDA listed
Tobramycin 3 mg/mL 63187-0024-05 Proficient 1 bottle AT FDA listed
Tobramycin 3 mg/mL 63187-0902-02 Proficient 1 bottle FDA listed
Tobramycin 3 mg/mL 63187-0973-05 Proficient 5 ml AT FDA listed
Tobramycin 3 mg/mL 66267-0936-05 NuCare 5 ml AT FDA listed
Tobramycin 3 mg/mL 68071-2272-05 NuCare 1 bottle AT FDA listed
Tobramycin 3 mg/mL 68083-0374-01 Gland 1 bottle AT FDA listed
Tobramycin 3 mg/mL 68788-7252-05 Preferred 1 bottle AT FDA listed
Tobramycin 3 mg/mL 70518-1370-00 REMEDYREPACK 1 bottle AT FDA listed
Tobramycin 3 mg/mL 71205-0101-05 Proficient 1 bottle AT FDA listed
Tobramycin 3 mg/mL 76420-0092-05 Asclemed 5 ml AT FDA listed
Tobramycin 3 mg/mL 76420-0791-05 Asclemed 1 bottle AT FDA listed
Tobramycin 3 mg/mL 80425-0341-01 Advanced 1 bottle AT FDA listed
Tobramycin 3 mg/mL 85766-0025-05 Sportpharm 1 bottle AT FDA listed
Tobramycin 3 mg/mL 85766-0189-05 Sportpharm 1 bottle AT FDA listed
Tobramycin 3 mg/mL 86211-0110-01 JVET 1 bottle AT FDA listed
Tobramycin 3 mg/mL 68788-4149-05 Preferred 1 bottle 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

🏛️
2024
On the market since
Apr 2024
📍
2026
Currently FDA-listed
2 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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Tobramycin — the program that covers self-administered drugs. 7 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Tobramycin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$564.7K
Claims incl. refills
354
Beneficiaries
253
Spend / beneficiary
$2,232.06
Spend / claim
$1,595.23
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
62250-0110-01 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (62250-110-01) / 5 mL in 1 BOTTLE, PLASTIC 2024-04-01 Active

🧭 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 FDA registers it as 62250-110-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 62250-0110-01, written without dashes as 62250011001. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 62250-0110-01, the first segment (62250) is the labeler code FDA assigned to Belcher Pharmaceuticals, LLC; the middle segment (0110) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Belcher Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Belcher Pharmaceuticals, LLC 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.

📄 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 62 words

INDICATIONS AND USAGE Tobramycin ophthalmic solution USP, 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin ophthalmic solution USP, 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.

⏱️ Dosage and Administration 41 words

DOSAGE AND ADMINISTRATION: In mild to moderate disease, instill 1 or 2 drops into the affected eye(s) every 4 hours. In severe infections, instill 2 drops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation.

Contraindications 18 words

CONTRAINDICATIONS Tobramycin ophthalmic solution USP, 0.3% is contraindicated in patients with known hypersensitivity to any of its components.

⚠️ Warnings 59 words

WARNINGS FOR TOPICAL OPHTHALMIC USE. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If a sensitivity reaction to tobramycin ophthalmic solution USP, 0.3% occurs, discontinue use.

🤒 Adverse Reactions 126 words

ADVERSE REACTIONS: The most frequent adverse reactions to tobramycin ophthalmic solution 0.3% are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treated with tobramycin ophthalmic solution. To report SUSPECTED ADVERSE REACTIONS, contact Belcher Pharmaceuticals, LLC at 1-727-471-0850 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Postmarketing Experience: Additional adverse reactions identified from post-marketing use include anaphylactic reaction, Stevens-Johnson syndrome, and erythema multiforme. The following additional adverse reactions have been reported with systemic aminoglycosides: Neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy. Aminoglycosides may aggravate muscle weakness in patients with known or suspected neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease, because of their potential effect on neuromuscular function.

🧬 Clinical Pharmacology 94 words

CLINICAL PHARMACOLOGY: In Vitro Data: In vitro studies have demonstrated tobramycin is active against susceptible strains of the following microorganisms: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae . Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

Bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant to gentamicin retain susceptibility to tobramycin.

📦 How Supplied / Storage and Handling 89 words

HOW SUPPLIED: 5 mL sterile solution supplied in opaque white low density polyethylene bottle which is closed with natural low density polyethylene nozzle and then with Tan colored high density polyethylene cap as follows: 5 mL containing tobramycin 0.3% (3 mg/mL)…. NDC 62250-110-01 Storage: Store at 2°C to 25°C (36°F to 77°F). After opening, Tobramycin Ophthalmic Solution, USP 0.3% can be used until the expiration date on the bottle.

Distributed by: Belcher Pharmaceuticals, LLC 6911 Bryan Dairy Road, Largo, FL 33777 USA Made in India January 2024 L100I R-2401

📋 Description 119 words

DESCRIPTION: Tobramycin ophthalmic solution USP, 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each mL of tobramycin ophthalmic solution USP, 0.3% contains: Active: tobramycin 0.3 % (3 mg). Preservative: benzalkonium chloride 0.01 % (0.1 mg).

Inactives: boric acid, sodium sulfate decahydrate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and water for injection. Tobramycin ophthalmic solution USP, 0.3% has a pH range between 7.0 and 8.0 and an osmolality of 260-320 mOsm/kg. Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens.

The chemical structure of tobramycin is: Molecular Weight = 467.52 Molecular Formula: C18H37N5O9 Chemical name: O-3-Amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribo- hexopyranosyl-(1→6)]-2-deoxy-L-streptamine. tobramycinstructure

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