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Tobramycin 3 mg/mL Solution

by Proficient Rx LP · 1 BOTTLE, DROPPER in 1 CARTON (63187-024-05) / 5 mL in 1 BOTTLE, DROPPER
NDC 63187-0024-05
🏷️ FDA NDC (as labeled) 63187-024-05 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 →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 63187-024-05
Product NDC 63187-024
11-digit billing NDC 63187002405
NCPDP billing unit ML — per mL (volume)
RxCUI 313415
UNII VZ8RRZ51VK
UPC 0363187024055
Application # ANDA064052
SPL Set ID d8235017-cb52-44d4-a6e6-6ee3f00c47d2
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 1993-11-29
Route OPHTHALMIC
Dosage form SOLUTION
Substance TOBRAMYCIN
GPI-14 86101070002005
GPI class Tobramycin
GCN Seq No 038588
GCN 09384
HICL code 017765
Ingredient (HICL) Tobramycin
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6W
Therapeutic class — specific (HIC3) Ophthalmic Antibiotics
AHFS code 08:12.02.00
AHFS class Aminoglycoside Antibiotics
FDB label name TOBRAMYCIN 0.3% EYE DROP
FDB brand name Tobramycin
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 63187-024-05 — 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 → 63187-0024-05. 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

LabelerProficient Rx LP
Application holderBAUSCH AND LOMB INC
FDA applicationANDA064052 (ANDA)
Labeler code63187
First marketedNov 1993
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.

🩺 Clinical

Label name TOBRAMYCIN 0.3% EYE DROP Ingredient Tobramycin
📗 Our plain-language guide HelloPharmacist
  • Tobramycin is an antibiotic, but the form you have determines exactly what it treats. If you're inhaling it through a nebulizer or using the TOBI Podhaler device, it's being used t...
  • That on-off cycle is by design. Inhaling tobramycin for 28 days helps knock back the Pseudomonas bacteria in your lungs, and then the 28-day break gives your body a rest and helps...
  • Why do I have to take the inhaled form for 28 days and then stop for 28 days?
  • Absolutely not — this is really important. The TOBI Podhaler capsules must never be swallowed. The medicine only works when it's inhaled directly into your lungs using the Podhaler...
📖 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.

🧪 Full Tobramycin nutrient depletion report →
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 $1.108 AT Availability likely —
Tobramycin 3 mg/mL 61314-0643-05 Sandoz 5 ml $1.108 AT Availability likely —
Tobramycin Ophthalmic Solution 3 mg/mL 62332-0518-05 Alembic 1 bottle $1.108 AT Availability likely —
Tobramycin 3 mg/mL 70069-0131-01 Somerset 1 bottle $1.108 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/mL 62250-0110-01 Belcher 1 bottle — AT FDA listed —
Tobramycin 3 mg/mLthis 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

🏛️
1993
On the market since
Nov 1993
📍
2026
Currently FDA-listed
33 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
63187-0024-05 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (63187-024-05) / 5 mL in 1 BOTTLE, DROPPER 2018-11-01 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 63187-024-05, 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: 63187-0024-05, written without dashes as 63187002405. 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 63187-0024-05, the first segment (63187) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0024) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 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.

📄 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 58 words ▾

INDICATIONS AND USAGE: Tobramycin Ophthalmic Solution 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. Clinical studies have shown tobramycin to be safe and effective for use in children.

⏱️ Dosage and Administration 54 words ▾

DOSAGE AND ADMINISTRATION: In mild to moderate disease, instill one or two drops into the affected eye(s) every four hours. In severe infections, instill two drops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation. DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. FOR OPHTHALMIC USE ONLY

⛔ Contraindications 16 words ▾

CONTRAINDICATIONS: Tobramycin Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of its components.

⚠️ Warnings 28 words ▾

WARNINGS: NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction to Tobramycin Ophthalmic Solution occurs, discontinue use.

🤒 Adverse Reactions 82 words ▾

ADVERSE REACTIONS: The most frequent adverse reactions to tobramycin ophthalmic solution is localized ocular toxicity and hypersensitivity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treated with tobramycin. Similar reactions may occur with the topical use of other aminoglycoside antibiotics.

Other adverse reactions have not been reported from tobramycin therapy; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.

🆘 Overdosage 33 words ▾

OVERDOSAGE: Clinically apparent signs and symptoms of an overdose of tobramycin ophthalmic solution (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.

🧬 Clinical Pharmacology 113 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-betahemolytic 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, and Acinetobacter calcoaceticus and some Neisseria species.

Bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant to gentamicin retain susceptibility to tobramycin. A significant bacterial population resistant to tobramycin has not yet emerged; however, bacterial resistance may develop upon prolonged use.

📦 How Supplied / Storage and Handling 69 words ▾

HOW SUPPLIED: Tobramycin Ophthalmic Solution USP, 0.3% is supplied in a plastic bottle with a controlled drop tip in the following size: 5 mL bottle – NDC 63187-024-05 Storage: Store at 2°-25°C (36°-77°F). Avoid excessive heat. KEEP OUT OF REACH OF CHILDREN. Revised August 2007 Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated 9116801 (Folded) 9116901 (Flat) Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

📦 Storage and Handling 41 words ▾

Storage: Store at 2°-25°C (36°-77°F). Avoid excessive heat. KEEP OUT OF REACH OF CHILDREN. Revised August 2007 Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated 9116801 (Folded) 9116901 (Flat) Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

📋 Description 106 words ▾

DESCRIPTION: Tobramycin ophthalmic solution is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external infections. EACH mL CONTAINS: ACTIVE: Tobramycin 3 mg (0.3%). INACTIVES: Boric Acid, Sodium Sulfate, Sodium Chloride, Tyloxapol and Purified Water.

Sodium Hydroxide and/or Sulfuric Acid may be added to adjust pH (7.0 - 8.0). PRESERVATIVE ADDED: Benzalkonium Chloride 0.1 mg (0.01%). The structural formula of tobramycin is Molecular formula: C 18 H 37 N 5 O 9 Molecular weight: 467.52 Chemical name: O-[3-amino-3-deoxy—α-D-gluco-pyranosyl-(1 → 4)]-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl- (1 → 6)]-2-deoxystreptamine.

Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. Tobramycin (structural formula)

💬 Information for Patients 17 words ▾

Information for patients: Do not touch dropper 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 ↗
← 63187-0023-25 · Proficient 63187-0025-15 · 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.