Tobramycin Ophthalmic Solution, USP 0.3%

Manufacturer: Akorn
Effective date: 2022-09-14
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-05-31 20:43:44

Label at a glance#

ProductTobramycin

Active ingredientTobramycin

Label structure12 sections

Indications and uses

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. Clinical studies have shown tobramycin to be safe and effective for use in children.

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.

Storage and handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from excessive heat. AKORN Manufactured by: Akorn Lake Forest, IL 60045 GTM00N Rev. 06/21

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Tobramycin Ophthalmic Solution USP, 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections.

Each mL contains:

Active: tobramycin 0.3% (3 mg). Inactives: boric acid, sodium chloride, sodium sulfate, tyloxapol, sodium hydroxide and/or sulfuric acid to adjust pH (7.0 to 8.0), and water for injection. Preservative: benzalkonium chloride 0.01% (0.1 mg).

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: C₁₈H₃₇N₅O₉

Chemical Name:

O-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4)}-O-{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1→6)}-2- deoxystreptamine.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

SPL UNCLASSIFIED SECTION

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.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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

WARNINGS

WARNINGS SECTION

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.

PRECAUTIONS

PRECAUTIONS SECTION

GENERAL PRECAUTIONS SECTION

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 SECTION

Information for Patients: Do not touch dropper tip to any surface, as this may contaminate the solution.

PREGNANCY SECTION

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 SECTION

Nursing Mothers: Because of the potential for adverse reactions in nursing infants from tobramycin, 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 SECTION

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

GERIATRIC USE SECTION

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

ADVERSE REACTIONS:

ADVERSE REACTIONS SECTION

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.

POSTMARKETING EXPERIENCE SECTION

Postmarketing Experience: Additional adverse reactions identified from postmarketing use include anaphylactic reaction, Stevens-Johnson syndrome, and erythema multiforme.

The following additional adverse reactions have been reported with systemic aminoglycosides: Neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy. Aminoglycosides may aggravate muscle weakness in patients with known or suspected neuromuscular disorders, such as myasthenia gravis or Parkinson's disease, because of their potential effect on neuromuscular function.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

HOW SUPPLIED

HOW SUPPLIED SECTION

Tobramycin Ophthalmic Solution USP, 0.3% is supplied as a sterile solution in white low-density polyethylene (LDPE) plastic dropper bottles in two sizes:

NDC 17478-290-20 . . . . . . . . . . . . 2 mL

NDC 17478-290-10 . . . . . . . . . . . . 5 mL

STORAGE

STORAGE AND HANDLING SECTION

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from excessive heat.

AKORN
Manufactured by: Akorn
Lake Forest, IL 60045

GTM00N Rev. 06/21

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-290-10

Tobramycin

Ophthalmic

Solution, USP

0.3%

Sterile

Rx only 5mL

Principal Display Panel Text for Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 17478-290-10

Tobramycin

Ophthalmic

Solution, USP

0.3%

Sterile

5 mL

Rx only Akorn

Principal Display Panel Text for Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
313415	tobramycin 0.3 % Ophthalmic Solution	PSN	7
313415	tobramycin 3 MG/ML Ophthalmic Solution	SCD	7
313415	tobramycin 0.3 % Ophthalmic Solution	SY	7

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
TOBRAMYCIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f297c7c1-845a-4369-8c02-c51b92d6ae8e	Product name	3	20240725
551d952d-4ce2-24f0-9ab0-630ad9aae596	Product name	2	20231211
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
941f67d9-7f03-56d2-750c-36de24f654db	Product name	3	20221117
9cfa145f-dbe9-bc02-83c2-692786ef6676	Product name	9	20210928
2f9713b8-5e7e-bbcc-b364-1b2c27a63796	Product name	4	20210903
32a533bc-01c7-2b9f-bbf7-ecfb0d964277	Product name	4	20210625
9f5124fb-08b0-4c3e-8e12-a1a6ff310cba	Product name	1	20150309
745a62af-e1c0-4ca3-6d6e-2b6455b903be	Product name	1	20140508
9ea85abb-fa68-5da6-ab60-2c7eef579000	Product name	1	20140508
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81	Product name	1	20140508
d029211e-5e6b-725f-3696-ac6ff77da222	Product name	1	20140508
ef5b7aed-2b01-3ba8-5a1c-3bc9c9f03bb1	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-290-10	2024-01-30	C162847	48780-1	1030e365-4077-111a-e063-dadaa90a10e2	Tobramycin Ophthalmic Solution, USP 0.3%
17478-290-20	2024-01-30	C162847	48780-1	1030e365-4077-111a-e063-dadaa90a10e2	Tobramycin Ophthalmic Solution, USP 0.3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17478-290-10	Tobramycin	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5	7
17478-290-10	Tobramycin	1 in 1 CARTON	SOLUTION/ DROPS	1	7
17478-290-20	Tobramycin	1 in 1 CARTON	SOLUTION/ DROPS	1	7
17478-290-20	Tobramycin	2 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	2	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-290	TOBRAMYCIN SOLUTION/ DROPS [AKORN]	7	Legacy NDC, 4 package rows	20220919_c91db5e0-f6b8-40d7-b307-b24073b9705e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-290-10	ML - Milliliter	17478-290	169807ad-6732-44b5-a494-c0ecee456d4c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Tobramycin	ACTIVE INGREDIENT	VZ8RRZ51VK	1
Tobramycin	ACTIVE MOIETY	VZ8RRZ51VK	1
Benzalkonium Chloride	INACTIVE INGREDIENT	F5UM2KM3W7	1
Boric Acid	INACTIVE INGREDIENT	R57ZHV85D4	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	1
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	1
sodium Sulfate	INACTIVE INGREDIENT	0YPR65R21J	1
Sulfuric Acid	INACTIVE INGREDIENT	O40UQP6WCF	1
Tyloxapol	INACTIVE INGREDIENT	Y27PUL9H56	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Tobramycin
Boric Acid
Sodium Chloride
sodium Sulfate
Tyloxapol
Sodium Hydroxide
Sulfuric Acid
WATER
Benzalkonium Chloride

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17478-290	17478-290-10, 17478-290-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Tobramycin	VZ8RRZ51VK	ACTIB
Boric Acid	R57ZHV85D4	IACT
Sodium Chloride	451W47IQ8X	IACT
sodium Sulfate	0YPR65R21J	IACT
Tyloxapol	Y27PUL9H56	IACT
Sodium Hydroxide	55X04QC32I	IACT
Sulfuric Acid	O40UQP6WCF	IACT
WATER	059QF0KO0R	IACT
Benzalkonium Chloride	F5UM2KM3W7	IACT

Source Document#

Source XML

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 7 · 392 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, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / SUBCUTANEOUS	0.8 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Tyloxapol	TYLOXAPOL	Y27PUL9H56	GEL / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 8 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / EPIDURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVENOUS		28773 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Boric Acid	BORIC ACID	R57ZHV85D4	SUSPENSION/ DROPS / AURICULAR (OTIC)		3 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
Tyloxapol	TYLOXAPOL	Y27PUL9H56	SUSPENSION / AURICULAR (OTIC)	0.05 %w/v		Exact identifier — unii candidate 8 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / NASAL	330 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Boric Acid	BORIC ACID	R57ZHV85D4	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	0.53 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	LIQUID / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / OPHTHALMIC		13 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Boric Acid	BORIC ACID	R57ZHV85D4	INJECTION, SOLUTION / INTRAVENOUS		210 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INHALANT / RESPIRATORY (INHALATION)	3 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / RETROBULBAR		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sulfuric Acid	SULFURIC ACID	O40UQP6WCF	INJECTION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	AEROSOL, METERED / RESPIRATORY (INHALATION)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACARDIAC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	0.68 %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
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	POWDER / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	CAPSULE, EXTENDED RELEASE / ORAL		41 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / EPIDURAL		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, DELAYED RELEASE / ORAL	0.25 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PERINEURAL		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / OPHTHALMIC		3 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAMUSCULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRALESIONAL		13 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium Sulfate	SODIUM SULFATE	0YPR65R21J	SOLUTION/ DROPS / OPHTHALMIC		13 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / INTRAMUSCULAR	9 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	POWDER, FOR SUSPENSION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / ORAL		148 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SPRAY / NASAL		30 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	ENEMA / RECTAL	0.44 %v/v		Exact identifier — unii candidate 174 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	INJECTION / INTRALESIONAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRATHECAL		131 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	DROPS / OPHTHALMIC	NA		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAPERITONEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Tyloxapol	TYLOXAPOL	Y27PUL9H56	SUSPENSION/ DROPS / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 8 equally ranked IID candidates
Sulfuric Acid	SULFURIC ACID	O40UQP6WCF	INJECTION / INTRAVENOUS	566 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRASPINAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / AURICULAR (OTIC)	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAMUSCULAR		17 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sulfuric Acid	SULFURIC ACID	O40UQP6WCF	INJECTION / EPIDURAL	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	TABLET, DELAYED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INFILTRATION	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRA-ARTERIAL	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

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
A064096-001	AKTOB	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC			1996-01-31

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064096-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064096-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064096-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064096-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064096-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064096-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064096-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064096-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064096-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064096-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064096-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064096-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064096-001	AT	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A064096-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064096-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064096-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064096-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064096-001	AT	1	`cb3db0bc1861…`

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
8893a898-9495-4eb6-800a-ede9227c83d8			c91db5e0-f6b8-40d7-b307-b24073b9705e	2022-09-14	Warnings, Adverse reactions	Exact identifier spl id: 8893a898-9495-4eb6-800a-ede9227c83d8 spl set id: c91db5e0-f6b8-40d7-b307-b24073b9705e

Reported adverse events (FAERS/openFDA)#

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