Tobramycin

Product NDC: 60940-027
11-digit product format: 609400027
Labeler code: 60940
Product ID: 60940-027_ca7de493-36d2-0934-e053-2995a90a95ab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tobramycin
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Holopack Verpackungstechnik GmbH
Application: ANDA212848
Marketing category: ANDA
Marketing start: 2021-08-31
Marketing end: 0000-00-00
Substance: TOBRAMYCIN
Active strength: 60 mg/mL
Pharmacologic classes: Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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
A212848-001	TOBRAMYCIN	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN		2021-04-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212848-001	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.

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	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212848-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2021-04-01	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212848-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212848-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212848-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212848-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212848-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212848-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212848-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212848-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212848-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212848-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212848-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212848-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212848-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212848-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212848-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212848-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212848-001	AN	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212848-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212848-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212848-001	AN	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212848-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212848-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212848-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212848-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212848-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212848-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212848-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212848-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212848-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212848-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212848-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212848-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212848-001	AN	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212848-001	AN	1	`a50c72e98297…`

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	Ascend Laboratories, LLC	845e3328-fffa-44eb-b78a-3607c05fdd55	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212848 application number: ANDA212848

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
60940-027-01	60940002701	56 POUCH in 1 CARTON (60940-027-01) > 7 AMPULE in 1 POUCH > 5 mL in 1 AMPULE	56 pouch	2021-08-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tobramycin Inhalation solution, for oral inhalation use	Holopack Verpackungstechnik GmbH	2021-08-26	HUMAN PRESCRIPTION DRUG LABEL	1