Tobramycin

Product NDC: 17478-340
Requested package NDC: 17478-340-38
11-digit product format: 174780340
Labeler code: 17478
Product ID: 17478-340_bc74ed3a-ecf1-43bf-b36c-1958d0578a8d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tobramycin
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Akorn
Application: ANDA201422
Marketing category: ANDA
Marketing start: 2014-05-29
Marketing end: 0000-00-00
Substance: TOBRAMYCIN
Active strength: 300 mg/5mL
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	17478-340	17478-340-38	D	Discontinued by firm		2026-08-03

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, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`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
A201422-001	TOBRAMYCIN	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN		2014-05-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A201422-001	AN

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	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201422-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2014-05-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201422-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201422-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201422-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201422-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201422-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201422-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201422-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201422-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201422-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201422-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201422-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201422-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201422-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201422-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201422-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201422-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201422-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201422-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201422-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201422-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201422-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201422-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201422-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201422-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201422-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201422-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201422-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201422-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201422-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201422-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201422-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201422-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201422-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201422-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201422-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201422-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201422-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201422-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201422-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201422-001	AN	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
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
17478-340-38	2024-01-30	C162847	48780-1	1030e365-50f8-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use TOBRAMYCIN INHALATION SOLUTION safely and effectively. See full prescribing information for TOBRAMYCIN INHALATION SOLUTION. TOBRAMYCIN inhalation solution, for oral inhalation use Initial U.S. Approval: 1975

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-340-38	ML - Milliliter	17478-340	42ccda22-7cde-4e29-9ef1-c24f8d7e2d5e	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Tobramycin	ACTIVE INGREDIENT	VZ8RRZ51VK	TOBRAMYCIN SOLUTION [AKORN, INC. ]	8
Tobramycin	ACTIVE MOIETY	VZ8RRZ51VK	TOBRAMYCIN SOLUTION [AKORN, INC. ]	8
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	TOBRAMYCIN SOLUTION [AKORN, INC. ]	8
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	TOBRAMYCIN SOLUTION [AKORN, INC. ]	8
Sulfuric Acid	INACTIVE INGREDIENT	O40UQP6WCF	TOBRAMYCIN SOLUTION [AKORN, INC. ]	8
Water	INACTIVE INGREDIENT	059QF0KO0R	TOBRAMYCIN SOLUTION [AKORN, INC. ]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-340	TOBRAMYCIN SOLUTION [AKORN]	16	Legacy NDC	20220919_be8368d7-bfd0-47e8-8d69-ac5f4a4851ed.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	Ritedose Pharmaceuticals, LLC	e8205898-0162-4e6c-bcf1-87cb074ab9ae	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201422 application number: ANDA201422

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-340-38	17478034038	14 POUCH in 1 CARTON (17478-340-38) > 4 AMPULE in 1 POUCH > 5 mL in 1 AMPULE	14 pouch	2014-05-29	0000-00-00	No	No	Current