Tobramycin

Product NDC: 68788-8248
11-digit product format: 687888248
Labeler code: 68788
Product ID: 68788-8248_1ff5edfb-18ae-4622-83fe-a6946f484016
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tobramycin
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA064052
Marketing category: ANDA
Marketing start: 2022-08-19
Marketing end: 0000-00-00
Substance: TOBRAMYCIN
Active strength: 3 mg/mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68788-8248		D	Discontinued by firm		2026-08-11
excluded package	package	68788-8248	68788-8248-5	D	Discontinued by firm		2026-08-11

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	68788-8248		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-8248	68788-8248-5	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A064052-001	TOBRAMYCIN	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		1993-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064052-001	AT

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	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`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	A064052-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064052-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064052-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064052-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064052-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064052-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064052-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064052-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064052-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064052-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064052-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064052-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064052-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064052-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064052-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064052-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064052-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064052-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064052-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064052-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064052-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064052-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064052-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064052-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064052-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064052-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064052-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064052-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064052-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064052-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064052-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064052-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064052-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064052-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064052-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064052-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064052-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064052-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064052-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064052-001	AT	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8248-5	ML - Milliliter	68788-8248	28cfed67-5c70-4122-af05-872482ac5506	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8248	TOBRAMYCIN SOLUTION [PREFERRED PHARMACEUTICALS INC.]	3	Legacy NDC	20240822_1ff5edfb-18ae-4622-83fe-a6946f484016.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tobramycin	TOBRAMYCIN	Preferred Pharmaceuticals Inc.	417623f1-ed48-41f5-a4b4-6f2e4a23891e	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064052 application number: ANDA064052
Tobramycin	TOBRAMYCIN	Sportpharm LLC	6ded47a3-d5c0-4616-8b7d-d6d0e6bce2a0	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064052 application number: ANDA064052
Tobramycin	TOBRAMYCIN	Advanced Rx Pharmacy of Tennessee, LLC	fc734c2d-0d45-195c-e053-6394a90a2a92	2024-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064052 application number: ANDA064052
Tobramycin	TOBRAMYCIN	NuCare Pharmaceuticals,Inc.	58b1fa9d-a302-6dc6-e053-2991aa0a3741	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064052 application number: ANDA064052
Tobramycin	TOBRAMYCIN	Asclemed USA, Inc.	c6f9c6b1-2c45-4f6b-a1fb-e55d74fc04c3	2024-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064052 application number: ANDA064052
Tobramycin	TOBRAMYCIN	Bausch & Lomb Incorporated	a5693ec9-d2f7-4d45-90b0-a113c54840d7	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064052 application number: ANDA064052
Tobramycin	TOBRAMYCIN	A-S Medication Solutions	774b608b-d6d9-4349-8772-11c69897be42	2023-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064052 application number: ANDA064052
Tobramycin	TOBRAMYCIN	Proficient Rx LP	d8235017-cb52-44d4-a6e6-6ee3f00c47d2	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064052 application number: ANDA064052

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	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8248-5	68788824805	1 BOTTLE, DROPPER in 1 CARTON (68788-8248-5) > 5 mL in 1 BOTTLE, DROPPER	2022-08-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tobramycin Ophthalmic Solution, USP 0.3% (Sterile) Rx only	Preferred Pharmaceuticals Inc.	2024-08-20	HUMAN PRESCRIPTION DRUG LABEL	3