GENTAMICIN SULFATE

Product NDC: 63187-163
11-digit product format: 631870163
Labeler code: 63187
Product ID: 63187-163_9bc97257-3fe5-45aa-a544-78d044982cd4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gentamicin sulfate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Proficient Rx LP
Application: ANDA062452
Marketing category: ANDA
Marketing start: 1998-01-05
Marketing end: 0000-00-00
Substance: GENTAMICIN SULFATE
Active strength: 3 mg/mL
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63187-163		D	Discontinued by firm		2026-08-11
excluded package	package	63187-163	63187-163-05	D	Discontinued by firm		2026-08-11

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A062452-001	GENOPTIC	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`cb3db0bc1861…`

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	A062452-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062452-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062452-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062452-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062452-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062452-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062452-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062452-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062452-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062452-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062452-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062452-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062452-001	AT	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A062452-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062452-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062452-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062452-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062452-001	AT	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-163-05	ML - Milliliter	63187-163	2c61686e-8569-4a5b-b17e-baf4ff130061	1	2016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
gentamicin sulfate	ACTIVE INGREDIENT	8X7386QRLV	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
gentamicin	ACTIVE MOIETY	T6Z9V48IKG	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
sodium phosphate, dibasic	INACTIVE INGREDIENT	GR686LBA74	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1
water	INACTIVE INGREDIENT	059QF0KO0R	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-163	GENTAMICIN SULFATE SOLUTION/ DROPS [PROFICIENT RX LP]	4	Legacy NDC	20220722_3ab508ed-4b12-4dd7-a13e-1a071f560286.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GENTAMICIN SULFATE	GENTAMICIN SULFATE	NuCare Pharmaceuticals,Inc.	85424b40-5c2d-421d-e053-2991aa0a7771	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062452 application number: ANDA062452
gentamicin sulfate	GENTAMICIN SULFATE	DIRECT RX	51a411a0-2671-4c1c-bf25-e29b32efed0c	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062452 application number: ANDA062452

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8X7386QRLV	GENTAMICIN SULFATE	1405-41-0	GENTAMICIN SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-163-05	63187016305	1 BOTTLE, DROPPER in 1 CARTON (63187-163-05) > 5 mL in 1 BOTTLE, DROPPER	2019-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GENTAMICIN SULFATE ophthalmic solution, USP 0.3% sterile	Proficient Rx LP	2022-07-01	HUMAN PRESCRIPTION DRUG LABEL	4