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Tobramycin 3 mg/mL Solution/ Drops

by Somerset Therapeutics, LLC · 1 BOTTLE in 1 CARTON (70069-131-01) / 5 mL in 1 BOTTLE
NDC 70069-0131-01
🏷️ FDA NDC (as labeled) 70069-131-01 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) 70069-131-01
Product NDC 70069-131
11-digit billing NDC 70069013101
NCPDP billing unit ML — per mL (volume)
RxCUI 313415
UNII VZ8RRZ51VK
UPC 0370069131015
Application # ANDA207444
SPL Set ID 7333280d-5d2a-4609-ab93-3ab7031b65db
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 2020-08-11
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
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 70069-131-01 — 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 → 70069-0131-01. 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

LabelerSomerset Therapeutics, LLC
Application holderSOMERSET THERAPEUTICS LLC
FDA applicationANDA207444 (ANDA)
Labeler code70069
First marketedAug 2020
Product typeHuman Prescription Drug
Portfolio183 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
📖 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
  • 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.

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 $1.108 $5.54 / 5 ml
Medicaid paysCMS SDUD · 12 mo $1.86 $9.29 / 5 ml
Medicare drug plans payPart D · Q2 2026 $0.9370 $4.69 / 5 ml
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $1.805 $1.002
▼ Down 8% over the last 24 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
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/mLthis 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/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

🏛️
2020
On the market since
Aug 2020
📍
2026
Currently FDA-listed
6 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.

🗺️ 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 70069-0131-01, 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 – Q1 2026 · 5 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
86.8K
Units reimbursed last 4 qtrs
446.4K
Gross reimbursed last 4 qtrs
$829.2K
Avg / prescription
$9.55
Avg / unit
$1.8576
Latest quarter Q1 2026
15.5KRx
Medicaid pays / mL
$1.8576
gross reimbursed
vs
NADAC / mL
$1.1081
acquisition cost
=
Spread
+$0.7495
+68% vs cost
What Medicaid paid per mL (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 ⓘ
30% FFS 70% MCO
Fee-for-service · 25,808 Rx Managed care · 60,983 Rx
State Medicaid map
Alaska: 70 units · 9.5 per 100k residents AK Maine: 770 units · 55.2 per 100k residents ME Washington: 7,540 units · 96.5 per 100k residents WA Idaho: 2,745 units · 140 per 100k residents ID Montana: 640 units · 56.5 per 100k residents MT North Dakota: 735 units · 93.9 per 100k residents ND Minnesota: 7,911 units · 138 per 100k residents MN Wisconsin: 4,115 units · 69.6 per 100k residents WI Michigan: 22,753 units · 227 per 100k residents MI New York: 54,762 units · 280 per 100k residents NY Vermont: 400 units · 61.8 per 100k residents VT New Hampshire: 695 units · 49.6 per 100k residents NH Oregon: 5,530 units · 131 per 100k residents OR Nevada: 4,290 units · 134 per 100k residents NV Wyoming: 920 units · 158 per 100k residents WY South Dakota: 1,065 units · 116 per 100k residents SD Iowa: 6,555 units · 204 per 100k residents IA Illinois: 18,395 units · 147 per 100k residents IL Indiana: 13,731 units · 200 per 100k residents IN Ohio: 26,435 units · 224 per 100k residents OH Pennsylvania: 21,797 units · 168 per 100k residents PA New Jersey: 21,297 units · 229 per 100k residents NJ Massachusetts: 868 units · 12.4 per 100k residents MA California: 27,527 units · 70.6 per 100k residents CA Utah: 2,260 units · 66.1 per 100k residents UT Colorado: 5,095 units · 86.7 per 100k residents CO Nebraska: 9,350 units · 473 per 100k residents NE Missouri: 1,343 units · 21.7 per 100k residents MO Kentucky: 7,220 units · 160 per 100k residents KY West Virginia: 3,615 units · 204 per 100k residents WV Virginia: 3,750 units · 43.0 per 100k residents VA Maryland: 10,256 units · 166 per 100k residents MD Connecticut: 2,645 units · 73.1 per 100k residents CT Rhode Island: 280 units · 25.6 per 100k residents RI Arizona: 11,510 units · 155 per 100k residents AZ New Mexico: 10,385 units · 491 per 100k residents NM Kansas: 1,660 units · 56.5 per 100k residents KS Arkansas: 2,105 units · 68.6 per 100k residents AR Tennessee: 7,445 units · 104 per 100k residents TN North Carolina: 7,489 units · 69.1 per 100k residents NC South Carolina: no data reported SC Delaware: 760 units · 73.7 per 100k residents DE Oklahoma: 7,215 units · 178 per 100k residents OK Louisiana: 12,980 units · 284 per 100k residents LA Mississippi: 2,795 units · 95.1 per 100k residents MS Alabama: 2,425 units · 47.5 per 100k residents AL Georgia: 8,398 units · 76.1 per 100k residents GA D.C.: 57 units · 8.4 per 100k residents DC Hawaii: 1,732 units · 121 per 100k residents HI Texas: 42,560 units · 140 per 100k residents TX Florida: 14,960 units · 66.2 per 100k residents FL
Units reimbursed · per 100k residents
8.4491
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 New Mexico 491 /100k
2 Nebraska 473 /100k
3 Louisiana 284 /100k
4 New York 280 /100k
5 New Jersey 229 /100k
6 Michigan 227 /100k
7 Ohio 224 /100k
8 Iowa 204 /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 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
70069-0131-01 You're viewing this 1 BOTTLE in 1 CARTON (70069-131-01) / 5 mL in 1 BOTTLE 2020-08-11 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 60 words ▾

INDICATIONS AND USAGE Tobramycin ophthalmic solution 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 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 17 words ▾

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

⚠️ Warnings 58 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 0.3% occurs, discontinue use.

🤒 Adverse Reactions 110 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 0.3%. 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 98 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 93 words ▾

HOW SUPPLIED Tobramycin ophthalmic solution USP, 0.3% is supplied as a 5 mL sterile solution, packaged in a 10 mL white LDPE bottle and natural LDPE nozzle and White HDPE cap as follows: 5 mL containing tobramycin 0.3% (3 mg/mL)… NDC 70069- 131 -01. Storage: Store at 2° to 25°C (36° to 77°F). After opening, tobramycin ophthalmic solution 0.3% can be used until the expiration date on the bottle.

For Product Inquiry call +1-800-417-9175 Revised: July, 2024 Manufactured for: Somerset Therapeutics, LLC Somerset, NJ 08873 Made in India Code No.: KR/DRUGS/KTK/28/289/97 1201000 ST-TBR11/P/07

📋 Description 126 words ▾

DESCRIPTION Tobramycin ophthalmic solution 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, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and water for injection. Tobramycin ophthalmic solution 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: C 18 H 37 N 5 O 9 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. Image

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.