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TOBRAMYCIN AND DEXAMETHASONE 3 mg/mL; 1 mg/mL Suspension/ Drops, 2.5 mL — NDC 63629-9570-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

TOBRAMYCIN AND DEXAMETHASONE 3 mg/mL; 1 mg/mL Suspension/ Drops, 2.5 mL — NDC 63629-9570-1 (Billing 63629-9570-01)

by Bryant Ranch Prepack · 2.5 mL in 1 BOTTLE, PLASTIC

This is a package of 2.5 mL of TOBRAMYCIN AND DEXAMETHASONE 3 mg/mL; 1 mg/mL Suspension/ Drops from Bryant Ranch Prepack, marketed since Mar 2022 and currently FDA-listed. It is this product's only package size.

NDC 63629-9570-01
🏷️ FDA NDC (as labeled) 63629-9570-1 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 Aug 27, 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 63629-9570-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63629 labeler · 9570 product · 1 package
Package marketed since
Dec 21, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
3 mL per package
Barcode (UPC-A, from the NDC)
3 6362995701 9
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63629-9570-1
Product NDC 63629-9570
11-digit billing NDC 63629957001
NCPDP billing unit ML — per mL (volume)
RxCUI 309683
UNII VZ8RRZ51VK, 7S5I7G3JQL
Application # ANDA212715
SPL Set ID 3c63c481-ce57-41ca-993f-5a5b665fa1e4
Established class (EPC) Aminoglycoside Antibacterial; Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
Chemical class Aminoglycosides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-03-17
Route OPHTHALMIC
Dosage form SUSPENSION/ DROPS
Substance TOBRAMYCIN; DEXAMETHASONE
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 007986
GCN 92280
HICL code 039399
Ingredient (HICL) Tobramycin/Dexamethasone
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 Q6I
Therapeutic class — specific (HIC3) Eye Antibiotic And Glucocorticoid Combinations
AHFS code 08:12.02.00
AHFS class Aminoglycoside Antibiotics
FDB label name TOBRAMYCIN-DEXAMETH OPHTH SUSP
FDB brand name Tobramycin-Dexamethasone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007986
  • GCN: 92280
  • HICL (First Databank): 039399
  • AHFS class code: 08:12.02.00
  • RxCUI (RxNorm): 309683
Why two NDCs? The FDA registers this code as 63629-9570-1 — 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 → 63629-9570-01. 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.

Clinical

Label name TOBRAMYCIN-DEXAMETH OPHTH SUSP Ingredient Tobramycin/Dexamethasone
📖 What it is MedlinePlus · NLM

Dexamethasone reduces the irritation, redness, burning, and swelling of eye caused by chemicals, heat, radiation, infection, allergy, or foreign bodies in the eye. It is sometimes used after eye surgery.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats inflammation in the eye when there is a bacterial infection or a risk of one. That includes inflammation of the front of the eye, chronic anterior uveitis, and injuries f...
  • It goes in the eye only. For drops, use the number of drops your prescriber directed, and shake Tobradex ST well first. For the ointment, place a small ribbon in the pocket of your...
  • Some people get eye pain, itchy or swollen eyelids, or redness. Blurry vision can happen briefly after Tobradex ST, so take care driving. Call your doctor if you get a rash, hives,...
  • Only as long as your prescriber says. Long steroid use can raise eye pressure and cause glaucoma or cataracts. If you use it for 10 days or longer, your eye pressure should be chec...
📖 Read our full Dexamethasone / Tobramycin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 $7.73 $19.34 / 2.5 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
63629-9570-01 You're viewing this Main listing 2.5 mL in 1 BOTTLE, PLASTIC 2022-12-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 00574-4031-05 Padagis 5 ml $4.012 AB Availability likely —
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 24208-0295-05 Bausch 1 bottle $4.012 AB Availability likely —
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 61314-0647-05 Sandoz 5 ml $4.012 AB Availability likely —
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 50090-1135-00 A-S 2.5 ml — AB FDA listed —
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 50090-1136-00 A-S 5 ml — AB FDA listed —
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 50090-1914-00 A-S 1 bottle — AB FDA listed —
Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 50090-7267-00 A-S 5 ml — AB FDA listed —
Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mLthis 63629-9570-01 Bryant 2.5 ml — AB FDA listed —
Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 63629-9571-01 Bryant 5 ml — AB FDA listed —
Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 63629-9572-01 Bryant 10 ml — AB FDA listed —
Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 67296-2174-05 Redpharm 5 ml — AB FDA listed —
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 68071-1821-02 NuCare 1 bottle — AB FDA listed —
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 68071-2418-02 NuCare 1 bottle — AB FDA listed —
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 68071-4203-05 NuCare 5 ml — AB FDA listed —
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 68788-4081-05 Preferred 1 bottle — AB FDA listed —
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 70518-3994-00 REMEDYREPACK 5 ml — AB FDA listed —
Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 71335-2840-01 Bryant 5 ml — AB FDA listed —
Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 71335-2854-01 Bryant 2.5 ml — AB FDA listed —
Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 71335-2891-01 Bryant 10 ml — AB FDA listed —
Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 72162-1128-02 Bryant 10 ml — AB FDA listed —
Tobramycin and dexamethasone 3 mg/mL; 1 mg/mL 80425-0260-01 Advanced 5 ml — AB FDA listed —
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 80425-0366-01 Advanced 5 ml — AB FDA listed —
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 85766-0188-05 Sportpharm 1 bottle — AB FDA listed —
Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 50090-8046-00 A-S 1 bottle — AB 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

🏛️
2022
On the market since
Mar 2022
📍
2026
Currently FDA-listed
4 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

LabelerBryant Ranch Prepack
Application holderPADAGIS US LLC
FDA applicationANDA212715 (ANDA)
Labeler code63629
First marketedMar 2022
Product typeHuman Prescription Drug
Portfolio4,436 products on file

More NDCs from Bryant Ranch Prepack labeler code 63629

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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 212 words ▾

INDICATIONS AND USAGE: Tobramycin and dexamethasone ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation.

They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: 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.

⏱️ Dosage and Administration 83 words ▾

DOSAGE AND ADMINISTRATION: One or two drops instilled into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one or two drops every two (2) hours. Frequency should be decreased gradually as warranted by improvement in clinical signs.

Care should be taken not to discontinue therapy prematurely. Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

⛔ Contraindications 36 words ▾

CONTRAINDICATIONS: Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication.

⚠️ Warnings 156 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 reaction, or bullous reactions. If a sensitivity reaction does occur, discontinue use. Prolonged use of steroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.

Intraocular pressure (IOP) should be routinely monitored even though it may be difficult in pediatric patients and uncooperative patients. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions and parasitic infections of the eye, steroids may mask infection or enhance existing infection.

In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS: Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available. The most frequent adverse reactions to topical ocular tobramycin (tobramycin ophthalmic solution) are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema.

These reactions occur in less than 4% of patients. The reactions due to the steroid component are: elevation of IOP with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. Secondary Infection: The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials.

Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.

Postmarketing Experience: Additional adverse reactions identified from post-marketing use include anaphylactic reaction, erythema multiforme. The following additional adverse reactions have been reported with the individual components listed below: Dexamethasone : Cushing's syndrome and adrenal suppression may occur after use of dexamethasone in excess of the listed dosing instructions in predisposed patients, including children and patients treated with CYP3A4 inhibitors. 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. To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 150 words ▾

Pregnancy: Corticosteroids have been found to be teratogenic in animal studies. Ocular administration of 0.1% dexamethasone resulted in 15.6% and 32.3% incidence of fetal anomalies in two groups of pregnant rabbits. Fetal growth retardation and increased mortality rates have been observed in rats with chronic dexamethasone therapy.

Reproduction studies have been performed in rats and rabbits with tobramycin at doses up to 100 mg/kg/day parenterally and have revealed no evidence of impaired fertility or harm to the fetus. There are no adequate and well-controlled studies in pregnant women. However, prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation.

Tobramycin and dexamethasone ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.

🧒 Pediatric Use 18 words ▾

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

🧓 Geriatric Use 17 words ▾

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

🧬 Clinical Pharmacology 170 words ▾

CLINICAL PHARMACOLOGY: Corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant. Dexamethasone is a potent corticoid.

The antibiotic component in the combination (tobramycin) is included to provide action against susceptible organisms. In vitro studies have demonstrated that 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. No data are available on the extent of systemic absorption from tobramycin and dexamethasone ophthalmic suspension; however, it is known that some systemic absorption can occur with ocularly applied drugs.

📦 How Supplied / Storage and Handling 88 words ▾

HOW SUPPLIED : Tobramycin and dexamethasone ophthalmic suspension, USP is sterile ophthalmic suspension supplied as a 2.5 mL suspension in a 5 mL natural polyethylene bottle respectively with a natural polyethylene controlled drop tip and a white polypropylene cap. NDC 63629-9570-1: 2.5 mL STORAGE: Store at 8°C to 27°C (46°F to 80°F). Store suspension upright and shake well before using.

After opening, tobramycin and dexamethasone ophthalmic suspension can be used until the expiration date on the bottle. Rx Only Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

📋 Description 125 words ▾

DESCRIPTION: Tobramycin and dexamethasone ophthalmic suspension USP is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use with a pH of approximately 5.5 and an osmolality of approximately 300 mOsm/kg. The chemical structures for tobramycin and dexamethasone are presented below: Tobramycin Empirical Formula: C 18 H 37 N 5 O 9 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 MW: 467.52 Dexamethasone Empirical Formula: C 22 H 29 FO 5 Chemical Name: 9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione MW: 392.47 Each mL of Tobramycin and dexamethasone ophthalmic suspension contains: Actives: tobramycin 0.3% (3 mg) and dexamethasone 0.1% (1 mg).

Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium dihydrate, hydroxyethyl cellulose, sodium chloride, sodium sulfate anhydrous, sulfuric acid and/or sodium hydroxide (to adjust pH), tyloxapol, and water for injection.

💬 Information for Patients 29 words ▾

Information for Patients: Do not touch dropper tip to any surface, as this may contaminate the contents. Contact lenses should not be worn during the use of this product.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS: General: The possibility of fungal infections of the cornea should be considered after long-term steroid dosing. As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.

When multiple prescriptions are required, or whenever clinical judgement dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy. Information for Patients: Do not touch dropper tip to any surface, as this may contaminate the contents.

Contact lenses should not be worn during the use of this product. Carcinogenesis, Mutagenesis, Impairment of Fertility: No studies have been conducted to evaluate the carcinogenic or mutagenic potential. No impairment of fertility was noted in studies of subcutaneous tobramycin in rats at doses of 50 and 100 mg/kg/day.

Pregnancy: Corticosteroids have been found to be teratogenic in animal studies. Ocular administration of 0.1% dexamethasone resulted in 15.6% and 32.3% incidence of fetal anomalies in two groups of pregnant rabbits. Fetal growth retardation and increased mortality rates have been observed in rats with chronic dexamethasone therapy.

Reproduction studies have been performed in rats and rabbits with tobramycin at doses up to 100 mg/kg/day parenterally and have revealed no evidence of impaired fertility or harm to the fetus. There are no adequate and well-controlled studies in pregnant women. However, prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation.

Tobramycin and dexamethasone ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism. Nursing Mothers: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when tobramycin and dexamethasone ophthalmic suspension is administered to a nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 37 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility: No studies have been conducted to evaluate the carcinogenic or mutagenic potential. No impairment of fertility was noted in studies of subcutaneous tobramycin in rats at doses of 50 and 100 mg/kg/day.

📄 Package Label / Principal Display Panel 6 words ▾

Tobramycin/Dexa Ophth Susp 0.3%-0.1% #2.5 Label

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

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 ✓ Available
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 Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bryant Ranch Prepack 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.
← 63629-9501-01 · Bryant 63629-9571-01 · Bryant →
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.