TOBRADEX ® (tobramycin and dexamethasone ophthalmic suspension) Sterile

Manufacturer: Alcon Laboratories, Inc.
Effective date: 2023-02-06
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 13
Source: legacy-cache
Hydrated at: 2026-08-01 21:38:01

Label at a glance#

ProductTobraDex

Active ingredientTOBRAMYCIN, DEXAMETHASONE

Label structure10 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

DESCRIPTION: TOBRADEX^® (tobramycin and dexamethasone ophthalmic suspension) is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use.

The chemical structures for tobramycin and dexamethasone are presented below:

Tobramycin

Empirical Formula: C₁₈H₃₇N₅O₉

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

Molecular Weight: 467.52

Dexamethasone

Empirical Formula: C₂₂H₂₉FO₅

Chemical Name: 9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione

Molecular Weight:392.47

Each mL of TOBRADEX^® (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, hydroxyethyl cellulose, purified water, sodium chloride, sodium sulfate, sulfuric acid and/or sodium hydroxide (to adjust pH), and tyloxapol.

CLINICAL PHARMACOLOGY SECTION

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 TOBRADEX; however, it is known that some systemic absorption can occur with ocularly applied drugs.

INDICATIONS & USAGE SECTION

INDICATIONS AND USAGE: TOBRADEX^® (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.

CONTRAINDICATIONS SECTION

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 SECTION

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 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.

PRECAUTIONS:

PRECAUTIONS SECTION

GENERAL PRECAUTIONS SECTION

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 SECTION

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 SECTION

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 SECTION

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. TOBRADEX (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 SECTION

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 TOBRADEX (tobramycin and dexamethasone ophthalmic suspension) is administered to a nursing woman.

PEDIATRIC USE SECTION

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

GERIATRIC USE SECTION

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

ADVERSE REACTIONS SECTION

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 [TOBREX (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 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 SECTION

Postmarketing Experience: Additional adverse reactions identified from postmarketing 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.

DOSAGE & ADMINISTRATION SECTION

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.

HOW SUPPLIED SECTION

HOW SUPPLIED: Sterile ophthalmic suspension in 2.5 mL (NDC 0065-0647-25), 5 mL (NDC 0065-0647-05) and 10 mL (NDC 0065-0647-10) dispensers.

STORAGE: Store at 8°C to 27°C (46°F to 80°F).

Store suspension upright and shake well before using.

After opening, TOBRADEX^® (tobramycin and dexamethasone ophthalmic suspension) can be used until the expiration date on the bottle.

Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936

T2021-63

May 2021

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0065-0647-25

Alcon^®
TobraDex^®
(tobramycin and dexamethasone ophthalmic suspension)

2.5 mL Sterile

PRINCIPAL DISPLAY PANEL 0065-0647-25 Alcon® TobraDex® (tobramycin and dexamethasone ophthalmic suspension) 2.5 mL Sterile

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-0647-05	ML - Milliliter	0065-0647	4211f1b8-db69-4229-b270-c2542cb50eaa	1	2012-07-24
0065-0647-10	ML - Milliliter	0065-0647	94230620-70ec-4165-b8c4-95ac977e47df	1	2012-07-24
0065-0647-25	ML - Milliliter	0065-0647	276e2de1-e78c-4ca2-afb7-304a6c844a3c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DEXAMETHASONE	ACTIVE INGREDIENT	7S5I7G3JQL	3
TOBRAMYCIN	ACTIVE INGREDIENT	VZ8RRZ51VK	3
DEXAMETHASONE	ACTIVE MOIETY	7S5I7G3JQL	3
TOBRAMYCIN	ACTIVE MOIETY	VZ8RRZ51VK	3
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	3
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	3
SODIUM SULFATE	INACTIVE INGREDIENT	0YPR65R21J	3
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	3
TYLOXAPOL	INACTIVE INGREDIENT	Y27PUL9H56	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

TobraDex
tobramycin and dexamethasone
TOBRAMYCIN
DEXAMETHASONE
BENZALKONIUM CHLORIDE
TYLOXAPOL
EDETATE DISODIUM
SODIUM CHLORIDE
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)
SODIUM SULFATE
SULFURIC ACID
SODIUM HYDROXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0065-0647	0065-0647-25, 0065-0647-05, 0065-0647-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TOBRAMYCIN	VZ8RRZ51VK	ACTIB
DEXAMETHASONE	7S5I7G3JQL	ACTIB
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
TYLOXAPOL	Y27PUL9H56	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	S38J6RZN16	IACT
SODIUM SULFATE	0YPR65R21J	IACT
SULFURIC ACID	O40UQP6WCF	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 467 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACAUDAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL		11 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / SOFT TISSUE	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / ORAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	POWDER, FOR SUSPENSION / ORAL		560 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LOTION, AUGMENTED / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAOCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SULFURIC ACID	SULFURIC ACID	O40UQP6WCF	INJECTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	POWDER, FOR SUSPENSION / ORAL		285 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	SUSPENSION / TOPICAL	0.69 %w/v		Exact identifier — unii candidate 15 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAVITREAL		6 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRA-ARTERIAL		278 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / URETHRAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRATUMOR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAPERITONEAL	0.54 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	LOTION / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / NASAL	40.46 mg/100ml		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / INTRATYMPANIC		2 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER / TOPICAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INFILTRATION		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / IONTOPHORESIS	0.6 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAOCULAR		320 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, EXTENDED RELEASE / ORAL	335.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SULFURIC ACID	SULFURIC ACID	O40UQP6WCF	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	POWDER, FOR SOLUTION / ORAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SULFURIC ACID	SULFURIC ACID	O40UQP6WCF	SOLUTION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / RECTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
TYLOXAPOL	TYLOXAPOL	Y27PUL9H56	SUSPENSION/ DROPS / TOPICAL	0.03 %w/v		Exact identifier — unii candidate 8 equally ranked IID candidates
SODIUM SULFATE	SODIUM SULFATE	0YPR65R21J	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INFILTRATION		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTABLE, LIPOSOMAL / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	OINTMENT / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SULFURIC ACID	SULFURIC ACID	O40UQP6WCF	SPRAY / NASAL		8 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBMUCOSAL		17 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUPPOSITORY / RECTAL		140 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	ELIXIR / ORAL	1.3 mg/5ml		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / TOPICAL		126 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ENDOTRACHEAL	7.6 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SUSPENSION / ENDOTRACHEAL	46.76 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	JELLY / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SUBMUCOSAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	IMPLANT / SUBCUTANEOUS	77 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, FILM COATED / ORAL		100 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRASYNOVIAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050592-001	TOBRADEX	DEXAMETHASONE; TOBRAMYCIN	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N050592-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N050592-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050592-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050592-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050592-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050592-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050592-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050592-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050592-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050592-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050592-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050592-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050592-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050592-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050592-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050592-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050592-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050592-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050592-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050592-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050592-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050592-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050592-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050592-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050592-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050592-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050592-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050592-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050592-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050592-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050592-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050592-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050592-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050592-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050592-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050592-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050592-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050592-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050592-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050592-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050592-001	AB	1	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
17119e04-12c0-47aa-87a6-8b6f385c5e87			22b59456-d26a-4f23-b052-3d73e00181eb	2023-02-06	Warnings, Adverse reactions	Exact identifier spl id: 17119e04-12c0-47aa-87a6-8b6f385c5e87 spl set id: 22b59456-d26a-4f23-b052-3d73e00181eb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.