Gentamicin Sulfate

Manufacturer: MWI | Akorn Operating Company LLC | Akorn
Effective date: 2022-01-27
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 22:11:06

Label at a glance#

ProductGentamicin Sulfate

Active ingredientGentamicin Sulfate

Label structure13 sections

Indications and uses

Gentamicin sulfate ophthalmic ointment is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharonconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus p...

Dosage and administration

Apply a small amount (approximately 1/2 inch ribbon) of ointment to the affected eye(s) two or three times a day.

Storage and handling

Store at 2° to 30°C (36° to 86°F). apexa™ Manufactured by: Akorn Inc. Lake Forest, IL 60045 Distributed by: MWI Boise, ID 83705 MWGK00N Rev. 07/14

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Ophthalmic Ointment USP, 0.3%

STERILE

Rx Only

DESCRIPTION:

DESCRIPTION SECTION

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

Gentamicin sulfate ophthalmic ointment is a sterile ointment for ophthalmic use. Each gram contains gentamicin sulfate equivalent to 3 mg gentamicin in a base of white petrolatum and mineral oil, with methylparaben and propylparaben as preservatives.

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 to buff 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 ophthalmic ointment is contraindicated in patients with known hypersensitivity to any of the components.

WARNINGS:

WARNINGS SECTION

NOT FOR INJECTION INTO THE EYE.

Gentamicin sulfate ophthalmic ointment 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.

Ophthalmic ointments may retard corneal healing.

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

Apply a small amount (approximately 1/2 inch ribbon) of ointment to the affected eye(s) two or three times a day.

HOW SUPPLIED:

HOW SUPPLIED SECTION

Gentamicin sulfate ophthalmic ointment USP, 0.3% is supplied in 3.5 g tube, box of one.

(NDC 13985-603-03)

STORAGE:

STORAGE AND HANDLING SECTION

Store at 2° to 30°C (36° to 86°F).

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

Distributed by: MWI
Boise, ID 83705

MWGK00N Rev. 07/14

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 13985-603-03

Gentamicin Sulfate STERILE

Ophthalmic Ointment USP, 0.3% Rx Only

(equivalent to 3 mg gentamicin per gram)

Apexa logo

AP 704005 Net Weight: 3.5g (1/8 oz)

Principal Display Panel Text for Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 13985-603-03

Gentamicin

Sulfate

Ophthalmic

Ointment

USP, 0.3%

(equivalent to

3 mg gentamicin

per gram)

STERILE

Rx Only

Apexa logo

AP 704005

Net Weight: 3.5g (1/8 oz)

Principal Display Panel Text for Carton Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Gentamicin Sulfate	ACTIVE INGREDIENT	8X7386QRLV	1
Gentamicin	ACTIVE MOIETY	T6Z9V48IKG	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	1
Mineral Oil	INACTIVE INGREDIENT	T5L8T28FGP	1
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	1
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	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
Methylparaben
Propylparaben
Petrolatum
Mineral Oil

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
13985-603	13985-603-03

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
Methylparaben	A2I8C7HI9T	IACT
Propylparaben	Z8IX2SC1OH	IACT
Petrolatum	4T6H12BN9U	IACT
Mineral Oil	T5L8T28FGP	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 · 195 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Methylparaben	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IRRIGATION	2 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	3.6 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / NASAL	26 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, DELAYED RELEASE / ORAL	5.67 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	DROPS / NASAL	14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CONCENTRATE / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 68 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SOAP / TOPICAL	0.82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SYSTEM / TRANSDERMAL	6.09 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRALESIONAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRALESIONAL	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / ORAL		346 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAVENOUS	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	0.4 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	FILM / BUCCAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, COATED / ORAL	1.5 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAMUSCULAR		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / VAGINAL		4084 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	LOTION / TOPICAL		1428 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SPRAY / TOPICAL		1379 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SPRAY / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION, CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 68 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
ad78dc06-1311-4d36-95c7-d59a419942c4			83851d99-d526-4a8b-b375-a3034bf3957a	2022-05-19	Warnings, Adverse reactions	Exact identifier spl set id: 83851d99-d526-4a8b-b375-a3034bf3957a

Reported adverse events (FAERS/openFDA)#

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