Tobramycin

Product NDC: 68083-312
Requested package NDC: 68083-312-06
11-digit product format: 680830312
Labeler code: 68083
Product ID: 68083-312_a13f2109-eb69-4d3a-9203-790cb6520e78
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tobramycin
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Gland Pharma Limited
Application: ANDA211189
Marketing category: ANDA
Marketing start: 2021-05-18
Substance: TOBRAMYCIN SULFATE
Active strength: 1.2 g/30mL
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A211189-001	TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-05-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211189-001	AP

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
2026-10-15 13:18:30	2026-09	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A211189-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A211189-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211189-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211189-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211189-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211189-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211189-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211189-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211189-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211189-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211189-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211189-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211189-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211189-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211189-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211189-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211189-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211189-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211189-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211189-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211189-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211189-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211189-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211189-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211189-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211189-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211189-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211189-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211189-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211189-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211189-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211189-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211189-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211189-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211189-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211189-001	AP	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOBRAMYCIN SULFATE	1.2 g/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
HJT0RXD7JK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
597823	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
38219f34-4859-428f-9ec1-06ead7604211	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	Strength	SPL version
68083-312-01	Tobramycin	30 mL in 1 VIAL, PHARMACY BULK PACKAGE	INJECTION, POWDER, LYOPHILIZED,	30		8
68083-312-06	Tobramycin	6 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	6		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-312	TOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED]	8	Current NDC, Legacy NDC, 2 package rows	20221021_38219f34-4859-428f-9ec1-06ead7604211.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tobramycin	TOBRAMYCIN	Northstar Rx LLC	55d09ffd-4f32-8aeb-3904-8a17db635e3a	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211189 application number: ANDA211189
Tobramycin	TOBRAMYCIN	Fosun Pharma USA Inc	c4751a4f-c9c1-60c5-e053-2995a90aeba9	2022-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211189 application number: ANDA211189
Tobramycin	TOBRAMYCIN	Gland Pharma Limited	38219f34-4859-428f-9ec1-06ead7604211	2022-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211189 application number: ANDA211189 ndc (package): 68083-312-06 ndc (product): 68083-312 ndc11 (package): 68083031206

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HJT0RXD7JK	TOBRAMYCIN SULFATE	49842-07-1	TOBRAMYCIN SULFATE
VZ8RRZ51VK	TOBRAMYCIN	32986-56-4	Tobramycin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
597823	tobramycin 40 MG/ML Injectable Solution	PSN	38219f34-4859-428f-9ec1-06ead7604211	8
597823	tobramycin 40 MG/ML Injectable Solution	SCD	38219f34-4859-428f-9ec1-06ead7604211	8
597823	tobramycin (as tobramycin sulfate) 40 MG/ML Injectable Solution	SY	38219f34-4859-428f-9ec1-06ead7604211	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68083-312-06	68083031206	6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68083-312-06) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (68083-312-01)	2021-05-18	0000-00-00	No	No	Current