Gentamicin Sulfate Ophthalmic Solution USP,0.3% Sterile

Manufacturer: Akorn | Akorn Operating Company LLC
Effective date: 2022-01-27
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 22:10:58

Label at a glance#

ProductGentamicin Sulfate

Active ingredientGentamicin Sulfate

Label structure12 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

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 SECTION

Microbiology: 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 PRECAUTIONS SECTION

General: 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 SECTION

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

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Carcinogenesis, Mutagenesis, Impairment of Fertility: There are no published carcinogenicity or impairment of fertility studies on gentamicin. Aminoglycoside antibiotics have been found to be non mutagenic.

PREGNANCY SECTION

Pregnancy: Pregnancy Category C. 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 SECTION

Pediatric Use: 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 17478-826-05)

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.

PREMIERProRx^®
Manufactured by: Akorn, Inc.
Lake Forest, IL 60045

PremierProRx^® is a registered trademark of Premier Inc., used under license.

PGK00N
Rev. 10/15

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-826-05

Gentamicin

Sulfate Ophthalmic

Solution, USP

0.3%

(equivalent to 3 mg

gentamicin per mL)

Rx only Sterile 5 mL

Premier Logo

Principal Display Panel Text for Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 17478-826-05

Gentamicin

Sulfate

Ophthalmic

Solution, USP

0.3%

(equivalent to 3 mg

gentamicin per mL)

Sterile

Rx only 5 mL

Premier Logo

Principal Display Panel Text for Carton Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-826-05	ML - Milliliter	17478-826	26c81f7e-29f9-4243-9ea0-7fc9becf7a19	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Gentamicin Sulfate	ACTIVE INGREDIENT	8X7386QRLV	1
Gentamicin	ACTIVE MOIETY	T6Z9V48IKG	1
Benzalkonium Chloride	INACTIVE INGREDIENT	F5UM2KM3W7	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	1
Sodium Phosphate, Dibasic, Anhydrous	INACTIVE INGREDIENT	22ADO53M6F	1
Sodium Phosphate, Monobasic	INACTIVE INGREDIENT	3980JIH2SW	1

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
17478-826	17478-826-05

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
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	CAPSULE / ORAL		6 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 Chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ORAL		1126 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 Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	TABLET / ORAL		96 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		2922 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, POWDER, FOR SUSPENSION / INTRA-ARTICULAR		45 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	GRANULE, FOR SUSPENSION / ORAL		162 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Phosphate, Monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SYSTEM / TOPICAL	14.2 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAPLEURAL	226 mg		Exact identifier — unii candidate 134 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
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRA-ARTICULAR		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 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	INJECTION / ENDOTRACHEAL		68 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
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	SOLUTION / INTRAVENOUS		90 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 / INTRACARDIAC		70 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 Chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET, FILM COATED / ORAL		100 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Phosphate, Monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	13.2 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / SUBCUTANEOUS		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	GEL / VAGINAL	10 %w/w		Exact identifier — unii candidate 134 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	INJECTION, EMULSION / INTRAVENOUS	0.28 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SUSPENSION / SOFT TISSUE		3 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		24 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 / INTRABURSAL	9 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / AURICULAR (OTIC)		3 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / EPIDURAL		648 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	SOLUTION / INTRAOCULAR		320 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
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SOLUTION / INTRAVENOUS		381 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVENOUS		28773 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SYRUP / ORAL		70 mg	Exact identifier — unii candidate 48 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 Chloride	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAVENOUS		6320 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRATHECAL		131 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SUSPENSION / OPHTHALMIC	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY, METERED / NASAL		1 mg	Exact identifier — unii candidate 24 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 Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL		11 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		1800 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / OPHTHALMIC		10 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
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	GEL / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 24 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 Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAVESICAL		351 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
Benzalkonium Chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / TOPICAL	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
Sodium Chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PERINEURAL		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
Sodium Phosphate, Dibasic, Anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SPRAY, METERED / NASAL		7 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 44.

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 · 44 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
2026-10-15 13:18:30	2026-09	A064163-001	GENTAK	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC		2001-10-12	`c2088c7a36db…`
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…`

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
45593152-4557-4351-baf7-cff4e7f9d709			32d5af97-70bd-4ee4-81d4-67578dc677a0	2022-05-20	Warnings, Adverse reactions	Exact identifier spl set id: 32d5af97-70bd-4ee4-81d4-67578dc677a0

Reported adverse events (FAERS/openFDA)#

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