Tobramycin

Product NDC: 13985-604
Requested package NDC: 13985-604-05
11-digit product format: 139850604
Labeler code: 13985
Product ID: 13985-604_2cf0b9a2-7c56-409e-8739-f3ed34fcb0d6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tobramycin
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: MWI
Application: ANDA064096
Marketing category: ANDA
Marketing start: 2015-03-27
Marketing end: 0000-00-00
Substance: TOBRAMYCIN
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	13985-604	13985-604-05	I	Inactivated by FDA		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
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 · 41 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
2026-02-19 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…`
2022-09-29 23:25 UTC	2022-09	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`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	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…`

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
13985-604-05	2024-01-30	C162847	48780-1	1030e365-4a66-111a-e063-dadaa90a10e2	49dbd938-6c66-4835-af7f-923267f4568d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
13985-604-05	Tobramycin	1 in 1 CARTON	SOLUTION/ DROPS	1		5
13985-604-05	Tobramycin	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Tobramycin	ACTIVE INGREDIENT	VZ8RRZ51VK	TOBRAMYCIN SOLUTION/ DROPS [MWI]	1
Tobramycin	ACTIVE MOIETY	VZ8RRZ51VK	TOBRAMYCIN SOLUTION/ DROPS [MWI]	1
Benzalkonium Chloride	INACTIVE INGREDIENT	F5UM2KM3W7	TOBRAMYCIN SOLUTION/ DROPS [MWI]	1
Boric Acid	INACTIVE INGREDIENT	R57ZHV85D4	TOBRAMYCIN SOLUTION/ DROPS [MWI]	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	TOBRAMYCIN SOLUTION/ DROPS [MWI]	1
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	TOBRAMYCIN SOLUTION/ DROPS [MWI]	1
Sodium Sulfate	INACTIVE INGREDIENT	0YPR65R21J	TOBRAMYCIN SOLUTION/ DROPS [MWI]	1
Sulfuric Acid	INACTIVE INGREDIENT	O40UQP6WCF	TOBRAMYCIN SOLUTION/ DROPS [MWI]	1
Tyloxapol	INACTIVE INGREDIENT	Y27PUL9H56	TOBRAMYCIN SOLUTION/ DROPS [MWI]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	TOBRAMYCIN SOLUTION/ DROPS [MWI]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13985-604	TOBRAMYCIN SOLUTION/ DROPS [MWI]	5	Legacy NDC, 2 package rows	20220208_49dbd938-6c66-4835-af7f-923267f4568d.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tobramycin	TOBRAMYCIN	Proficient Rx LP	ac497300-eb1e-4021-b504-89f19e1eb0f3	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064096 application number: ANDA064096

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VZ8RRZ51VK	TOBRAMYCIN	32986-56-4	TOBRAMYCIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313415	tobramycin 0.3 % Ophthalmic Solution	PSN	49dbd938-6c66-4835-af7f-923267f4568d	5
313415	tobramycin 3 MG/ML Ophthalmic Solution	SCD	49dbd938-6c66-4835-af7f-923267f4568d	5
313415	tobramycin 0.3 % Ophthalmic Solution	SY	49dbd938-6c66-4835-af7f-923267f4568d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
13985-604-05	13985060405	1 BOTTLE, DROPPER in 1 CARTON (13985-604-05) > 5 mL in 1 BOTTLE, DROPPER	2015-03-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tobramycin - MWI \| Akorn Operating Company LLC \| Akorn	MWI \| Akorn Operating Company LLC \| Akorn	2022-02-07	HUMAN PRESCRIPTION DRUG LABEL	5