Tobramycin

Product NDC: 10544-883
11-digit product format: 105440883
Labeler code: 10544
Product ID: 10544-883_1622f31d-3a6a-2887-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tobramycin
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA064096
Marketing category: ANDA
Marketing start: 2015-05-15
Marketing end: 0000-00-00
Substance: TOBRAMYCIN
Active strength: 3 mg/mL
Pharmacologic classes: Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	10544-883		I	Inactivated by FDA		2026-08-10
excluded package	package	10544-883	10544-883-99	I	Inactivated by FDA		2026-08-10

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-883-99	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-883-99	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-883-99	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-883-99	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-883-99	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-883-99	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-883-99	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-883-99	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-883-99	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-883-99	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10544-883-99	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10544-883-99	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10544-883-99	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10544-883-99	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10544-883-99	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10544-883-99	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10544-883-99	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10544-883-99	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10544-883-99	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10544-883-99	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	10544-883-99	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	10544-883-99	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A064096-001	AKTOB	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC			1996-01-31

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	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC		1996-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064096-001	AKTOB	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1996-01-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064096-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064096-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064096-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064096-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064096-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064096-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064096-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064096-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064096-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064096-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064096-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064096-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064096-001	AT	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A064096-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064096-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064096-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064096-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064096-001	AT	1	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10544-883-99	2020-01-31	C162847	48780-1	9d75b9d0-196f-f424-e053-dadaa90a57ce	Tobramycin Ophthalmic Solution, USP 0.3%–Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-883-99	Tobramycin	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5		1
10544-883-99	Tobramycin	1 in 1 CARTON	SOLUTION/ DROPS	1		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOBRAMYCIN	ACTIVE INGREDIENT	VZ8RRZ51VK	TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.]	1
TOBRAMYCIN	ACTIVE MOIETY	VZ8RRZ51VK	TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.]	1
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.]	1
SODIUM SULFATE	INACTIVE INGREDIENT	0YPR65R21J	TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.]	1
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.]	1
TYLOXAPOL	INACTIVE INGREDIENT	Y27PUL9H56	TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-883	TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.]	1	Legacy NDC, 2 package rows	20150515_1622f31d-3a69-2887-e054-00144ff8d46c.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	Proficient Rx LP	ac497300-eb1e-4021-b504-89f19e1eb0f3	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064096 application number: ANDA064096

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
313415	tobramycin 0.3 % Ophthalmic Solution	PSN	1622f31d-3a69-2887-e054-00144ff8d46c	1
313415	tobramycin 3 MG/ML Ophthalmic Solution	SCD	1622f31d-3a69-2887-e054-00144ff8d46c	1
313415	tobramycin 0.3 % Ophthalmic Solution	SY	1622f31d-3a69-2887-e054-00144ff8d46c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
10544-883-99	10544088399	5 mL in 1 BOTTLE, DROPPER	5 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tobramycin Ophthalmic Solution, USP 0.3%–Sterile	Blenheim Pharmacal, Inc.	2015-05-15	HUMAN PRESCRIPTION DRUG LABEL	1