timolol maleate

Product NDC: 81469-209
11-digit product format: 814690209
Labeler code: 81469
Product ID: 81469-209_b666fc6c-b409-45a6-a890-fa5b41585390
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: timolol maleate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: First Nation Group, LLC
Application: ANDA078771
Marketing category: ANDA
Marketing start: 2024-05-10
Substance: TIMOLOL MALEATE
Active strength: 2.5 mg/mL
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078771-001	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1		2009-09-28
A078771-002	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1		2009-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078771-001	AT1
A078771-002	AT1

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 3 · 84 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
2026-08-18 06:07:40	2026-07	A078771-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078771-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078771-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078771-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078771-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078771-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078771-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078771-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078771-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078771-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078771-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078771-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078771-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078771-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078771-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078771-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078771-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078771-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078771-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078771-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078771-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078771-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078771-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078771-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078771-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078771-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078771-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078771-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078771-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078771-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078771-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078771-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078771-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078771-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078771-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078771-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078771-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078771-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078771-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078771-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2009-09-28	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078771-001	AT1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078771-002	AT1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078771-001	AT1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078771-002	AT1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078771-001	AT1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078771-002	AT1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078771-001	AT1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078771-002	AT1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078771-001	AT1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078771-002	AT1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078771-001	AT1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078771-002	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078771-001	AT1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078771-002	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078771-001	AT1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078771-002	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078771-001	AT1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078771-002	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078771-001	AT1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078771-002	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078771-001	AT1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078771-002	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078771-001	AT1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078771-002	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078771-001	AT1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078771-002	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078771-001	AT1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078771-002	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078771-001	AT1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078771-002	AT1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078771-001	AT1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078771-002	AT1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078771-001	AT1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078771-002	AT1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078771-001	AT1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078771-002	AT1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078771-001	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078771-002	AT1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078771-001	AT1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078771-002	AT1	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: timolol maleate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TIMOLOL MALEATE	2.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
P8Y54F701R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1923428	Internal RxNorm lookup
1992303	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
140e1bfc-b75e-40d1-856c-242be4d9c8cc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791	Product name	4	20251208
73103a56-9f57-4f32-a306-a42bfa2fea36	Product name	1	20250505
425025fc-f910-4afe-815b-58d4486ed4f7	Product name	4	20250331
26c5ddae-5c69-622d-e599-5fd583634968	Product name	4	20250313
ee780602-134c-4c60-a2f0-e973ba549cd4	Product name	2	20250304
03f77cb2-b4ad-3c11-8781-787b5ece4291	Product name	3	20240507
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
273981e4-09e7-45cc-967c-554f628ededf	Product name	3	20230627
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
97dad5a2-c524-a7b5-dede-82edefe9ce62	Product name	7	20220929
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
d11e749b-f93e-0ce3-ceda-28fe03d8081d	Product name	2	20190731
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
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	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
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
81469-209-05	timolol maleate	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5	1
81469-209-05	timolol maleate	1 in 1 CARTON	SOLUTION/ DROPS	1	1
81469-209-10	timolol maleate	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10	1
81469-209-10	timolol maleate	1 in 1 CARTON	SOLUTION/ DROPS	1	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81469-209-05	ML - Milliliter	81469-209	2d44a9e5-b75d-4f3c-bee9-424737b98c45	1	2024-08-12
81469-209-10	ML - Milliliter	81469-209	a733a093-134f-4e15-a6fe-545f6676cd41	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81469-209	TIMOLOL MALEATE SOLUTION/ DROPS [FIRST NATION GROUP, LLC]	1	Current NDC, 4 package rows	20240510_140e1bfc-b75e-40d1-856c-242be4d9c8cc.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
timolol maleate	TIMOLOL MALEATE	NorthStar RxLLC	9db7322d-eb31-4fff-9b14-8a0294d01704	2024-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078771 application number: ANDA078771
timolol maleate	TIMOLOL MALEATE	First Nation Group, LLC	140e1bfc-b75e-40d1-856c-242be4d9c8cc	2024-03-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078771 application number: ANDA078771 ndc (product): 81469-209
timolol maleate	TIMOLOL MALEATE	Lifestar Pharma LLC	545b7bee-8d5d-4206-b973-8de3c14d6dfe	2023-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078771 application number: ANDA078771

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P8Y54F701R	TIMOLOL MALEATE	26921-17-5	TIMOLOL MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1992303	timolol 0.5 % 12HR Ophthalmic Solution	PSN	140e1bfc-b75e-40d1-856c-242be4d9c8cc	1
1923428	timolol maleate 0.25 % Ophthalmic Solution	PSN	140e1bfc-b75e-40d1-856c-242be4d9c8cc	1
1992303	12 HR timolol 5 MG/ML Ophthalmic Solution	SCD	140e1bfc-b75e-40d1-856c-242be4d9c8cc	1
1923428	timolol 2.5 MG/ML Ophthalmic Solution	SCD	140e1bfc-b75e-40d1-856c-242be4d9c8cc	1
1923428	timolol 0.25 % Ophthalmic Solution	SY	140e1bfc-b75e-40d1-856c-242be4d9c8cc	1
1992303	timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic Solution	SY	140e1bfc-b75e-40d1-856c-242be4d9c8cc	1
1992303	timolol 0.5 % 12 HR Ophthalmic Solution	SY	140e1bfc-b75e-40d1-856c-242be4d9c8cc	1
1923428	timolol 2.5 MG/ML (as timolol maleate 3.4 MG/ML) Ophthalmic Solution	SY	140e1bfc-b75e-40d1-856c-242be4d9c8cc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
81469-209-05	81469020905	1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 5 mL in 1 BOTTLE, DROPPER	2024-05-10	No	No	Current
81469-209-10	81469020910	1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 10 mL in 1 BOTTLE, DROPPER	2024-05-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
STERILE OPHTHALMIC SOLUTION Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% Rx only	First Nation Group, LLC \| Mankind Pharma Limited	2024-03-07	HUMAN PRESCRIPTION DRUG LABEL	1