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Tobramycin 3 mg/mL Solution/ Drops — NDC 68788-7252-5 (Billing 68788-7252-05)

by Preferred Pharmaceuticals Inc. · 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE

This is a package of Tobramycin 3 mg/mL Solution/ Drops from Preferred Pharmaceuticals Inc., marketed since Aug 2018 and currently FDA-listed. It is this product's only package size.

NDC 68788-7252-05
🏷️ FDA NDC (as labeled) 68788-7252-5 billing pads the package 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 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

NDC database record

One package, one record: these facts belong to NDC 68788-7252-5 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
68788 labeler · 7252 product · 5 package
Package marketed since
Aug 29, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6878872525 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68788-7252-5
Product NDC 68788-7252
11-digit billing NDC 68788725205
NCPDP billing unit ML — per mL (volume)
RxCUI 313415
UNII VZ8RRZ51VK
Application # ANDA207444
SPL Set ID ad61ce34-8305-4fd3-bf88-a1e2438128cc
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 2018-08-29
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance TOBRAMYCIN
TE code (Orange Book) AT · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 86101070002005
GPI class Tobramycin
Quick answers
  • GPI-14 (Medi-Span): 86101070002005
  • RxCUI (RxNorm): 313415
Why two NDCs? The FDA registers this code as 68788-7252-5 — a 5-4-1 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 package segment → 68788-7252-05. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It depends on the form. Inhaled tobramycin treats Pseudomonas aeruginosa lung infection in cystic fibrosis. Eye drops and ointment treat external eye infections. The injection trea...
  • You breathe it in by mouth, usually twice a day about 12 hours apart, for 28 days. Then you take 28 days off. TOBI Podhaler capsules must never be swallowed; they are used only wit...
  • Cough, shortness of breath, fever, sore throat, hoarseness and headache are common with the inhaled form. Mention them to your care team if they bother you.
  • Call about ringing in the ears, hearing loss, dizziness or balance trouble, new muscle weakness, or wheezing after a dose. These can be signs of serious effects.
📖 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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68788-7252-05 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE 2018-08-29 — Active

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/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/mLthis 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

🏛️
2018
On the market since
Aug 2018
📍
2026
Currently FDA-listed
8 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.

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.

Manufacturer & labeler

LabelerPreferred Pharmaceuticals Inc.
Application holderSOMERSET THERAPEUTICS LLC
FDA applicationANDA207444 (ANDA)
Labeler code68788
First marketedAug 2018
Product typeHuman Prescription Drug
Portfolio833 products on file

More NDCs from Preferred Pharmaceuticals Inc. labeler code 68788

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 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 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 96 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/mL0) NDC 68788-7252-5. 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: June, 2021 Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024 Made in India Code No.: KR/DRUGS/KTK/28/289/97 PSSO0377 ST-TBR11/P/05 Relabeled By: Preferred Pharmaceuticals Inc.,

📋 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

⚠️ Precautions ~1 min read ▾

PRECAUTIONS General: As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy.

Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial ocular infection. Information for Patients: Do not touch dropper tip to any surface, as this may contaminate the solution. Pregnancy: Reproduction studies in 3 types of animals at doses up to 33 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. Nursing Mothers: Because of the potential for adverse reactions in nursing infants from tobramycin ophthalmic solution 0.3%, a decision should be made whether to discontinue nursing the infant or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 2 months has not been established. Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

📄 Package Label / Principal Display Panel 29 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Tobramycin Ophthalmic Solution 0.3% 5 mL Container Label A close-up of a yellow and black text AI-generated content may be incorrect.Tobramycin Ophthalmic Sol USP 0.3%

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

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.

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 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 Preferred Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Preferred Pharmaceuticals Inc. 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.
← 68788-7251-01 · Preferred 68788-7264-01 · Preferred →
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.