TOBRAMYCIN

Product NDC: 59651-129
Requested package NDC: 59651-129-56
11-digit product format: 596510129
Labeler code: 59651
Product ID: 59651-129_faec0c96-e264-6fee-e053-6394a90a23ca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TOBRAMYCIN
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Aurobindo Pharma Limited
Application: ANDA210871
Marketing category: ANDA
Marketing start: 2021-01-22
Substance: TOBRAMYCIN
Active strength: 300 mg/5mL
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A210871-001	TOBRAMYCIN	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION			2021-01-22

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.

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	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-01-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-01-22	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210871-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2021-01-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210871-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210871-001	AN	1	`5aa47cf7b7d7…`

Additional Listing Data#

Finished product: Yes
Brand name base: TOBRAMYCIN
Listing expiration: 2026-12-31

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
0aa5859e-cd80-49c0-881b-47f39d1f1d01	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
941f67d9-7f03-56d2-750c-36de24f654db	Product name	3	20221117
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
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
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
9f5124fb-08b0-4c3e-8e12-a1a6ff310cba	Product name	1	20150309
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
745a62af-e1c0-4ca3-6d6e-2b6455b903be	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9ea85abb-fa68-5da6-ab60-2c7eef579000	Product name	1	20140508
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
d029211e-5e6b-725f-3696-ac6ff77da222	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	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
59651-129-04	TOBRAMYCIN	4 in 1 POUCH	SOLUTION	4	6
59651-129-04	TOBRAMYCIN	5 mL in 1 AMPULE	SOLUTION	5	6
59651-129-56	TOBRAMYCIN	14 in 1 CARTON	SOLUTION	14	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-129	TOBRAMYCIN SOLUTION [AUROBINDO PHARMA LIMITED]	6	Current NDC, Legacy NDC, 3 package rows	20230520_0aa5859e-cd80-49c0-881b-47f39d1f1d01.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	Aurobindo Pharma Limited	0aa5859e-cd80-49c0-881b-47f39d1f1d01	2023-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210871 application number: ANDA210871 ndc (package): 59651-129-56 ndc (product): 59651-129 ndc11 (package): 59651012956

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	0aa5859e-cd80-49c0-881b-47f39d1f1d01	6
348719	tobramycin 60 MG/ML Inhalation Solution	SCD	0aa5859e-cd80-49c0-881b-47f39d1f1d01	6
348719	tobramycin 300 MG per 5 ML Inhalation Solution	SY	0aa5859e-cd80-49c0-881b-47f39d1f1d01	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59651-129-56	59651012956	14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE	14 pouch	2021-01-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TOBRAMYCIN	Aurobindo Pharma Limited \| Eugia Pharma Specialities Limited	2023-05-18	HUMAN PRESCRIPTION DRUG LABEL	6