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TOBREX tobramycin 3 mg/g Ointment, 3.5 g — NDC 00078-0813-01 package photo

TOBREX tobramycin 3 mg/g Ointment, 3.5 g

by Novartis Pharmaceuticals Corporation · 3.5 g in 1 TUBE (0078-0813-01)
NDC 00078-0813-01
🏷️ FDA NDC (as labeled) 0078-0813-01 billing pads the labeler segment with a zero
Rx only Brand 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) 0078-0813-01
Product NDC 0078-0813
11-digit billing NDC 00078081301
NCPDP billing unit GM — per gram (weight)
RxCUI 207850, 313414
UNII VZ8RRZ51VK
Application # NDA050555
SPL Set ID 5b66bba3-cf97-4a9c-b618-ba5f277f20f6
Established class (EPC) Aminoglycoside Antibacterial
Chemical class Aminoglycosides
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1981-06-28
Route OPHTHALMIC
Dosage form OINTMENT
Substance TOBRAMYCIN
GPI-14 86101070004205
GCN Seq No 038587
GCN 09383
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 TOBREX 0.3% EYE OINTMENT
FDB brand name Tobrex
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 0078-0813-01 — a 4-4-2 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 labeler segment → 00078-0813-01. 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

LabelerNovartis Pharmaceuticals Corporation
Application holderNOVARTIS PHARMACEUTICALS CORP
FDA applicationNDA050555 (NDA)
Labeler code00078
First marketedJun 1981
Product typeHuman Prescription Drug
Portfolio209 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 TOBREX 0.3% EYE OINTMENT Ingredient Tobramycin
📖 What it is MedlinePlus · NLM

Ophthalmic tobramycin is used to treat eye infections. Tobramycin is in a class of medications called antibiotics. It works by killing bacteria that cause infections.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Tobrex ointment treats bacterial infections of the eye and the skin and tissue right around it — like bacterial conjunctivitis (pink eye caused by bacteria) or eyelid infections. I...
  • What kind of eye infection does this treat?
  • It's easier than it sounds. Tilt your head back, then gently pull your lower eyelid down with a finger to create a small pocket. Squeeze a ribbon of ointment — about half an inch —...
  • How do I actually apply the eye ointment without making a mess?
📖 Read our full Tobramycin Ophthalmic 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 HM4YQM8WRC
    Chlorobutanol is a colorless crystalline chemical used as a preservative in medicines. It prevents bacterial and fungal growth to maintain product safety and shelf life.
  • 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.

3 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 gPer package
Retail pharmacies payNADAC · weekly $84.516 $295.81 / 3.5 g
Medicaid paysCMS SDUD · 12 mo $78.47 $274.65 / 3.5 g
Medicare drug plans payPart D · Q2 2026 $83.53 $292.36 / 3.5 g
NADAC price history (per g) — tap or hover for the price & month
Sep 2022 Jan 2024 May 2026 Aug 2026 $84.703 $61.593
▲ Up 37% over the last 10 months.
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
Tobrex 3 mg/gthis 00078-0813-01 Novartis 3.5 g $84.516 Availability likely
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
1981
On the market since
Jun 1981
📍
2026
Currently FDA-listed
45 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00078-0813-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.6K
Units reimbursed last 4 qtrs
6K
Gross reimbursed last 4 qtrs
$474K
Avg / prescription
$288.13
Avg / unit
$78.4714
Latest quarter Q4 2025
353Rx
Medicaid pays / g
$78.4714
gross reimbursed
vs
NADAC / g
$84.5164
acquisition cost
=
Spread
−$6.0450
-7% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
20% FFS 80% MCO
Fee-for-service · 323 Rx Managed care · 1,322 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 42 units · 0.7 per 100k residents WI Michigan: no data reported MI New York: 214 units · 1.1 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 777 units · 6.2 per 100k residents IL Indiana: 245 units · 3.6 per 100k residents IN Ohio: 830 units · 7.0 per 100k residents OH Pennsylvania: 137 units · 1.1 per 100k residents PA New Jersey: 655 units · 7.1 per 100k residents NJ Massachusetts: 88 units · 1.3 per 100k residents MA California: 373 units · 1.0 per 100k residents CA Utah: no data reported UT Colorado: 81 units · 1.4 per 100k residents CO Nebraska: no data reported NE Missouri: 228 units · 3.7 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 46 units · 0.7 per 100k residents MD Connecticut: 245 units · 6.8 per 100k residents CT Rhode Island: no data reported RI Arizona: 182 units · 2.4 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 39 units · 0.4 per 100k residents GA D.C.: 63 units · 9.3 per 100k residents DC Hawaii: no data reported HI Texas: 1,621 units · 5.3 per 100k residents TX Florida: 179 units · 0.8 per 100k residents FL
Units reimbursed · per 100k residents
0.49.3
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 D.C. 9.3 /100k
2 New Jersey 7.1 /100k
3 Ohio 7.0 /100k
4 Connecticut 6.8 /100k
5 Illinois 6.2 /100k
6 Texas 5.3 /100k
7 Missouri 3.7 /100k
8 Indiana 3.6 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Tobrex — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Tobrex. 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
$301.7K
Claims incl. refills
940
Beneficiaries
815
Spend / beneficiary
$370.17
Spend / claim
$320.95
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Tobramycin — the ingredient across all brands.

Top reported reactions

Death1,776
Pneumonia1,621
Infective Pulmonary Exacerbation Of Cystic Fibrosis1,591
Dyspnoea1,542
Cough1,369
Cystic Fibrosis1,294
Hospitalisation1,068

Age at onset

Neonate52
Infant41
Child354
Adolescent305
Adult2,278
Elderly951

Reporter sex

28,038 reports
Male · 44%
Female · 56%
Unknown · 0%

Serious outcomes

Hospitalization12,468
Death3,042
Life-threatening889
Disabling453
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,457 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00078-0813-01 You're viewing this 3.5 g in 1 TUBE (0078-0813-01) 2022-03-08 Active

📄 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 64 words

INDICATIONS AND USAGE TOBREX ® (tobramycin ophthalmic ointment) 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 TOBREX (tobramycin ophthalmic ointment) 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.

⏱️ Dosage and Administration 127 words

DOSAGE AND ADMINISTRATION In mild to moderate disease, apply a half-inch ribbon into the affected eye(s) 2 or 3 times per day. In severe infections, instill a half-inch ribbon into the affected eye(s) every 3 to 4 hours until improvement, following which treatment should be reduced prior to discontinuation. How to Apply TOBREX (tobramycin ophthalmic ointment) 0.3%: 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 ½ inch) of TOBREX ® (tobramycin ophthalmic ointment) 0.3% in the ''V'' pocket. Do not let the tip of the tube touch your eye.

4. Look downward before closing your eye.

Contraindications 19 words

CONTRAINDICATIONS TOBREX (tobramycin ophthalmic ointment) 0.3 % is contraindicated in patients with known hypersensitivity to any of its components.

⚠️ Warnings 55 words

WARNINGS 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 TOBREX (tobramycin ophthalmic ointment) 0.3% occurs, discontinue use.

🤒 Adverse Reactions 113 words

ADVERSE REACTIONS: The most frequent adverse reactions to TOBREX (tobramycin ophthalmic ointment) 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 TOBREX ® (tobramycin ophthalmic ointment) 0.3%. Postmarketing Experience: Additional adverse reactions identified from postmarketing 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.

🤰 Pregnancy 66 words

Pregnancy: Reproduction studies in three types of animals at doses up to thirty-three times the normal human systemic dose have revealed no evidence of impaired fertility or harm to the fetus due to tobramycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 18 words

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 2 months has not been established.

🧓 Geriatric Use 20 words

Geriatric Use: No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.

🧬 Clinical Pharmacology 104 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 81 words

HOW SUPPLIED TOBREX (tobramycin ophthalmic ointment) 0.3% is supplied as a 3.5 g sterile ointment in an aluminum tube with a white polyethylene tip and white polyethylene cap as follows: 3.5 g containing tobramycin 0.3% (3 mg/g).................................................. NDC 0078-0813-01 Storage: Store at 2°C to 25°C (36°F to 77°F). After opening, TOBREX (tobramycin ophthalmic ointment) 0.3% can be used until the expiration date on the tube.

Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 © Novartis Revised: June 2021 T2021-76

📋 Description 91 words

DESCRIPTION TOBREX ® (tobramycin ophthalmic ointment) 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each gram of TOBREX (tobramycin ophthalmic ointment) 0.3% contains: Active: tobramycin 0.3% (3 mg). Preservative: chlorobutanol 0.5%.

Inactives: mineral oil, white petrolatum. 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 Formula: C 18 H 37 N 5 O 9 Molecular Weight: 467.52 g/mol Chemical Name: 0-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4) }-0-{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1→6) }-2-deoxystreptamine. chemical structure of tobramycin

💬 Information for Patients 32 words

Information for Patients: Do not touch tube tip to any surface, as this may contaminate the ointment. Do not use the product if the imprinted carton seals have been damaged, or removed.

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.