Gentamicin Sulfate Ophthalmic Solution USP, 0.3%

Manufacturer: Akorn | Akorn Operating Company LLC
Effective date: 2022-01-27
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 20:39:45

Label at a glance#

ProductGentamicin Sulfate

Active ingredientGentamicin Sulfate

Label structure13 sections

Indications and uses

Gentamicin Sulfate Sterile Ophthalmic Solution is indicated in the topical treatment of ocular bacterial infections, including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptoc...

Dosage and administration

Gentamicin Sulfate sterile ophthalmic solution; Instill one or two drops into the affected eye(s) every four hours. In severe infections, dosage may be increased to as much as two drops once every hour.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Sterile

Rx only

DESCRIPTION

DESCRIPTION SECTION

Gentamicin sulfate is a water-soluble antibiotic of the aminoglycoside group.

Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution for ophthalmic use.

Each mL contains:
Active: Gentamicin Sulfate USP (equivalent to 3 mg gentamicin base)
Preservative: Benzalkonium Chloride
Inactives: Disodium Phosphate, Monosodium Phosphate, and Sodium Chloride. The pH range is from 6.8 to 7.3.

Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C₁, C₂, and C_1A. All three components appear to have similar antimicrobial activities. Gentamicin sulfate occurs as a white powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Microbiology

MICROBIOLOGY SECTION

Gentamicin sulfate is active in vitro against many strains of the following microorganisms:

Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Gentamicin Sulfate Sterile Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of the components.

WARNINGS

WARNINGS SECTION

NOT FOR INJECTION INTO THE EYE. Gentamicin Sulfate Ophthalmic Solution is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.

PRECAUTIONS

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible organisms including fungi. Bacterial resistance to gentamicin may also develop. If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.

If irritation or hypersensitivity to any component of the drug develops, the patient should discontinue use of this preparation and appropriate therapy should be instituted.

Information for patients

INFORMATION FOR PATIENTS SECTION

To avoid contamination, do not touch tip of container to the eye, eyelid or any surface.

Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

There are no published carcinogenicity or impairment of fertility studies on gentamicin. Aminoglycoside antibiotics have been found to be non mutagenic.

Pregnancy

PREGNANCY SECTION

Pregnancy Category C

SPL UNCLASSIFIED SECTION

Gentamicin has been shown to depress body weights, kidney weights and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose. There are no adequate and well-controlled studies in pregnant women. Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pediatric Use

PEDIATRIC USE SECTION

Safety and effectiveness in neonates have not been established.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Bacterial and fungal corneal ulcers have developed during treatment with gentamicin ophthalmic preparations.

The most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non-specific conjunctivitis, conjunctival epithelial defects and conjunctival hyperemia.

Other adverse reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura and hallucinations.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

HOW SUPPLIED

HOW SUPPLIED SECTION

Gentamicin Sulfate ophthalmic solution - Sterile, 5-mL plastic dropper bottle, box of one. (NDC 17478-283-10)

STORAGE AND HANDLING SECTION

STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Avoid exposure to excessive heat.

SPL UNCLASSIFIED SECTION

Akorn

Manufactured by: Akorn, Inc.
Lake Forest, IL 60045

GK00N

Rev. 06/16

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-283-10

Gentamicin

Sulfate Ophthalmic

Solution, USP

0.3%

(equivalent to 3 mg

gentamicin per mL)

Sterile

Rx only 5 mL

Principal Display Panel Text for Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 17478-283-10

Gentamicin

Sulfate

Ophthalmic

Solution, USP

0.3%

(equivalent to 3 mg

gentamicin per mL)

5 mL

Sterile

Rx only Akorn Logo

Principal Display Panel Text for Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310467	gentamicin sulfate 0.3 % Ophthalmic Solution	PSN	5
310467	gentamicin 3 MG/ML Ophthalmic Solution	SCD	5
310467	gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Solution	SY	5
310467	gentamicin sulfate 3 MG/ML Ophthalmic Solution	SY	5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
3b7b3a7a-635f-32a3-0c6c-7ad028e3de91	Product name	2	20250107
43025f0d-698c-68da-cec9-ea4261a7ef7a	Product name	2	20250107
d3946667-8212-d1f2-67e1-5643a329bb56	Product name	2	20200403
4ce5dce5-e8a7-e4f6-0059-b527e4307477	Product name	2	20190501
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-283-10	2024-01-30	C162847	48780-1	1030e365-6862-111a-e063-dadaa90a10e2	Gentamicin Sulfate Ophthalmic Solution USP, 0.3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17478-283-10	Gentamicin Sulfate	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5		5
17478-283-10	Gentamicin Sulfate	1 in 1 CARTON	SOLUTION/ DROPS	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-283	GENTAMICIN SULFATE SOLUTION/ DROPS [AKORN]	5	Legacy NDC, 2 package rows	20220129_877ab1fd-6c0e-42f6-9522-f5efaa96018d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-283-10	ML - Milliliter	17478-283	fce35808-f7cd-423b-b3af-66b516a33394	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Gentamicin Sulfate	ACTIVE INGREDIENT	8X7386QRLV	2
Gentamicin	ACTIVE MOIETY	T6Z9V48IKG	2
Benzalkonium Chloride	INACTIVE INGREDIENT	F5UM2KM3W7	2
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	2
Sodium Phosphate, Dibasic, Anhydrous	INACTIVE INGREDIENT	22ADO53M6F	2
Sodium Phosphate, Monobasic	INACTIVE INGREDIENT	3980JIH2SW	2

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Gentamicin Sulfate
Gentamicin
Sodium Phosphate, Dibasic, Anhydrous
Sodium Phosphate, Monobasic
Sodium Chloride
Benzalkonium Chloride

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17478-283	17478-283-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Gentamicin Sulfate	8X7386QRLV	ACTIM
Sodium Phosphate, Dibasic, Anhydrous	22ADO53M6F	IACT
Sodium Phosphate, Monobasic	3980JIH2SW	IACT
Sodium Chloride	451W47IQ8X	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 4 · 215 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
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	INJECTION, SOLUTION / SUBARACHNOID	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / TOPICAL	0.01 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SOLUTION/ DROPS / OPHTHALMIC	1.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / TOPICAL	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	ELIXIR / ORAL	1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY, METERED / NASAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	DROPS / OPHTHALMIC	0.08 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / TOPICAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SOLUTION / OPHTHALMIC	1.21 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / AURICULAR (OTIC)		18 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	FILM, SOLUBLE / ORAL	0.05 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBMUCOSAL		17 mg	Exact identifier — unii candidate 134 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	INJECTION, SUSPENSION / INTRAVITREAL		6 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SOLUTION / INTRATHECAL		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, EMULSION / INTRAVENOUS	0.28 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / AURICULAR (OTIC)	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL	1.35 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	AEROSOL, FOAM / TOPICAL	0.09 %w/w		Exact identifier — unii candidate 48 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 / PERIDURAL	8.07 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRALESIONAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		360 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
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SUSPENSION / INTRALESIONAL		3 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAOCULAR		320 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INSERT / INTRAOCULAR	0.02 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAVENOUS		6320 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SHAMPOO / TOPICAL		150 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 Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	LOZENGE / TRANSMUCOSAL		112 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 134 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
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	LIQUID / NASAL	0.2 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / PARENTERAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION / INTRA-ARTICULAR		28 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	TABLET, FOR SUSPENSION / ORAL		60 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SYSTEM / TOPICAL	3.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRATUMOR	1.2 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Phosphate, Monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SOLUTION / ORAL	25 mg/5ml		Exact identifier — unii candidate 9 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION / INTRAVENOUS		381 mg	Exact identifier — unii candidate 48 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	SPRAY, METERED / NASAL		36 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	CLOTH / TOPICAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
Sodium Phosphate, Monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION, SUSPENSION / SUBCUTANEOUS	0.07 %w/v		Exact identifier — unii candidate 9 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SOLUTION / NASAL	5 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	CREAM / TOPICAL	0.36 %w/w		Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SYSTEM / IONTOPHORESIS	3.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAPERITONEAL	0.54 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ORAL		1126 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	LIQUID / SUBCUTANEOUS	0.7 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SOLUTION / ORAL		140 mg	Exact identifier — unii candidate 48 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
A064163-001	GENTAK	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			2001-10-12

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	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2001-10-12	`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	A064163-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064163-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064163-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064163-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064163-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064163-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064163-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064163-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064163-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064163-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064163-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064163-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064163-001	AT	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A064163-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064163-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064163-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064163-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064163-001	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
b09bb7e8-6fdf-42a3-b56b-07676e04d387			877ab1fd-6c0e-42f6-9522-f5efaa96018d	2022-01-27	Warnings, Adverse reactions	Exact identifier spl id: b09bb7e8-6fdf-42a3-b56b-07676e04d387 spl set id: 877ab1fd-6c0e-42f6-9522-f5efaa96018d

Reported adverse events (FAERS/openFDA)#

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