Tobramycin Inhalation Solution

Product NDC: 16714-119
Requested package NDC: 16714-119-03
11-digit product format: 167140119
Labeler code: 16714
Product ID: 16714-119_ad71fb36-9238-ab3b-a5c4-9d284a63b27d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tobramycin Inhalation Solution
Dosage form: INHALANT
Route: RESPIRATORY (INHALATION)
Labeler: NorthStar RxLLC
Application: ANDA207080
Marketing category: ANDA
Marketing start: 2020-05-21
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	16714-119	16714-119-03	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
A207080-001	TOBRAMYCIN	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN		2018-07-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207080-001	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	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207080-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2018-07-09	`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	A207080-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207080-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207080-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207080-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207080-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207080-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207080-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207080-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207080-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207080-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207080-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207080-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207080-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207080-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207080-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207080-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207080-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207080-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207080-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207080-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207080-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207080-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207080-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207080-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207080-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207080-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207080-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207080-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207080-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207080-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207080-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207080-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207080-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207080-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207080-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207080-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207080-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207080-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207080-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207080-001	AN	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tobramycin Inhalation Solution
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOBRAMYCIN	300 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VZ8RRZ51VK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
348719	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3d044738-a715-fdee-7849-521e8981e6ec	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16714-119-02	Tobramycin Inhalation Solution	5 mL in 1 AMPULE	INHALANT	5	6
16714-119-03	Tobramycin Inhalation Solution	14 in 1 CARTON	INHALANT	14	6
16714-119-03	Tobramycin Inhalation Solution	4 in 1 POUCH	INHALANT	4	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-119-02	ML - Milliliter	16714-119	c29ac690-15aa-4ffa-ac00-d3be416ed737	1	2020-06-05
16714-119-03	ML - Milliliter	16714-119	5f3ce6a0-7e15-4ed4-8b66-3df078f8d4c4	1	2020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-119	TOBRAMYCIN INHALATION SOLUTION INHALANT [NORTHSTAR RXLLC]	6	Legacy NDC, 3 package rows	20241219_3d044738-a715-fdee-7849-521e8981e6ec.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
Tobramycin Inhalation Solution	TOBRAMYCIN INHALATION SOLUTION	NorthStar RxLLC	3d044738-a715-fdee-7849-521e8981e6ec	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207080 application number: ANDA207080 ndc (package): 16714-119-03 ndc (product): 16714-119 ndc11 (package): 16714011903
Tobramycin Inhalation Solution	TOBRAMYCIN INHALATION SOLUTION	Dr. Reddy's Laboratories Inc.	e5bbf589-d066-c89a-c40f-cbeb6f98c5b5	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207080 application number: ANDA207080

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
348719	tobramycin 300 MG in 5 ML Inhalation Solution	PSN	3d044738-a715-fdee-7849-521e8981e6ec	6
348719	tobramycin 60 MG/ML Inhalation Solution	SCD	3d044738-a715-fdee-7849-521e8981e6ec	6
348719	tobramycin 300 MG per 5 ML Inhalation Solution	SY	3d044738-a715-fdee-7849-521e8981e6ec	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-119-03	16714011903	14 POUCH in 1 CARTON (16714-119-03) > 4 AMPULE in 1 POUCH > 5 mL in 1 AMPULE (16714-119-02)	14 pouch	2020-05-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tobramycin Inhalation Solution	NorthStar RxLLC \| Holopack Verpackungstechnik GmbH	2026-07-09	HUMAN PRESCRIPTION DRUG LABEL	7