Brimonidine Tartrate/Timolol Maleate

Product NDC: 60505-6225
11-digit product format: 605056225
Labeler code: 60505
Product ID: 60505-6225_27c9a4e3-a7a1-4294-8645-8f46bc529d71
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: brimonidine tartrate, timolol maleate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Apotex Corp
Application: NDA021398
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2022-01-19
Marketing end: 0000-00-00
Substance: BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Active strength: 2 mg/mL; mg/mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Adrenergic beta-Antagonists [MoA], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Blocker [EPC]
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	60505-6225		D	Discontinued by firm	2026-08-07
excluded package	package	60505-6225	60505-6225-0	D	Discontinued by firm	2026-08-07
excluded package	package	60505-6225	60505-6225-1	D	Discontinued by firm	2026-08-07
excluded package	package	60505-6225	60505-6225-2	D	Discontinued by firm	2026-08-07

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60505-6225-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60505-6225-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60505-6225-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60505-6225-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60505-6225-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60505-6225-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60505-6225-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60505-6225-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60505-6225-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60505-6225-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60505-6225-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60505-6225-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60505-6225-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60505-6225-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60505-6225-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60505-6225-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60505-6225-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60505-6225-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60505-6225-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60505-6225-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60505-6225-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60505-6225-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60505-6225-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60505-6225-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60505-6225-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60505-6225-0	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60505-6225-1	`0efc9e666f02…`	`f202fb6c5f17…`

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
N021398-001	COMBIGAN	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021398-001	AB

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2007-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2007-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2007-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2007-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2007-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2007-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2007-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2007-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2007-10-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2007-10-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2007-10-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021398-001	COMBIGAN	0.2%;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AB	RLD, RS	2007-10-30	`cb3db0bc1861…`

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	N021398-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021398-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021398-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021398-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021398-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021398-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021398-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021398-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021398-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021398-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021398-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021398-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021398-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021398-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021398-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021398-001	AB	1	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021398-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021398-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021398-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021398-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021398-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021398-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021398-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021398-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021398-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021398-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021398-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021398-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021398-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021398-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 188 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021398-001	7030149	2022-04-19	U-849			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021398-001	7320976	2022-04-19	U-849			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021398-001	7642258	2022-04-19	U-1024	Drug substance, Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021398-001	8133890	2022-04-19	U-1235		2012-04-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021398-001	8354409	2022-04-19	U-1371	Drug product	2013-03-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021398-001	8748425	2022-04-19	U-1524	Drug product	2014-07-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021398-001	9474751	2022-04-19	U-1524	Drug product	2016-10-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021398-001	9770453	2022-04-19	U-2131	Drug product	2017-10-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021398-001	9907801	2022-04-19	U-2239	Drug product	2018-03-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021398-001	9907802	2022-04-19	U-2240	Drug product	2018-03-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021398-001	7030149	2022-04-19	U-849			`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021398-001	7320976	2022-04-19	U-849			`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021398-001	7642258	2022-04-19	U-1024	Drug substance, Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021398-001	8133890	2022-04-19	U-1235		2012-04-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021398-001	8354409	2022-04-19	U-1371	Drug product	2013-03-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021398-001	8748425	2022-04-19	U-1524	Drug product	2014-07-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021398-001	9474751	2022-04-19	U-1524	Drug product	2016-10-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021398-001	9770453	2022-04-19	U-2131	Drug product	2017-10-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021398-001	9907801	2022-04-19	U-2239	Drug product	2018-03-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021398-001	9907802	2022-04-19	U-2240	Drug product	2018-03-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021398-001	7323463	2023-01-19		Drug product, Delist requested		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021398-001	7030149	2022-04-19	U-849			`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021398-001	7320976	2022-04-19	U-849			`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021398-001	7642258	2022-04-19	U-1024	Drug substance, Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021398-001	8133890	2022-04-19	U-1235		2012-04-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021398-001	8354409	2022-04-19	U-1371	Drug product	2013-03-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021398-001	8748425	2022-04-19	U-1524	Drug product	2014-07-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021398-001	9474751	2022-04-19	U-1524	Drug product	2016-10-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021398-001	9770453	2022-04-19	U-2131	Drug product	2017-10-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021398-001	9907801	2022-04-19	U-2239	Drug product	2018-03-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021398-001	9907802	2022-04-19	U-2240	Drug product	2018-03-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021398-001	7323463	2023-01-19		Drug product, Delist requested		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021398-001	7030149	2022-04-19	U-849			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021398-001	7320976	2022-04-19	U-849			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021398-001	7642258	2022-04-19	U-1024	Drug substance, Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021398-001	8133890	2022-04-19	U-1235		2012-04-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021398-001	8354409	2022-04-19	U-1371	Drug product	2013-03-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021398-001	8748425	2022-04-19	U-1524	Drug product	2014-07-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021398-001	9474751	2022-04-19	U-1524	Drug product	2016-10-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021398-001	9770453	2022-04-19	U-2131	Drug product	2017-10-12	`74a2ff9319b5…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-6225-0	ML - Milliliter	60505-6225	e4bbba07-0539-4ec7-8339-7ea5b30ee932	1	2022-02-07
60505-6225-1	ML - Milliliter	60505-6225	a31563ae-1fcd-4a52-bbeb-7a860103d0a7	1	2022-02-07
60505-6225-2	ML - Milliliter	60505-6225	d0f5cd10-7280-4b72-b289-8bb6c5c86b35	1	2022-02-07

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
COMBIGAN	BRIMONIDINE TARTRATE, TIMOLOL MALEATE	Allergan, Inc.	feaf1480-a4b8-4486-992a-96be3a596243	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021398 application number: NDA021398

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4S9CL2DY2H	BRIMONIDINE TARTRATE	70359-46-5	BRIMONIDINE TARTRATE
P8Y54F701R	TIMOLOL MALEATE	26921-17-5	TIMOLOL MALEATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-6225-0	60505622500	1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) > 5 mL in 1 BOTTLE, DROPPER	2022-01-19	0000-00-00	No	No	Current
60505-6225-1	60505622501	1 BOTTLE, DROPPER in 1 CARTON (60505-6225-1) > 10 mL in 1 BOTTLE, DROPPER	2022-01-19	0000-00-00	No	No	Current
60505-6225-2	60505622502	1 BOTTLE, DROPPER in 1 CARTON (60505-6225-2) > 15 mL in 1 BOTTLE, DROPPER	2022-01-19	0000-00-00	No	No	Current