Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%

Product NDC: 46708-546
11-digit product format: 467080546
Labeler code: 46708
Product ID: 46708-546_9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA212942
Marketing category: ANDA
Marketing start: 2020-11-22
Substance: TIMOLOL MALEATE
Active strength: 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
A212942-001	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22
A212942-002	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212942-001	AB
A212942-002	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 · 74 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
2026-08-18 06:07:40	2026-07	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A212942-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212942-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212942-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212942-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212942-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212942-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212942-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212942-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212942-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212942-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212942-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212942-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212942-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212942-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212942-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212942-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212942-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212942-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212942-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212942-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212942-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212942-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212942-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212942-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212942-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212942-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212942-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212942-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212942-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212942-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212942-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212942-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212942-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212942-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212942-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212942-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212942-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212942-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212942-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212942-002	AB	1	`782e0a99824c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A212942-001	CGT	2021-05-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212942-002	CGT	2021-05-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212942-001	CGT	2021-05-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212942-002	CGT	2021-05-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212942-001	CGT	2021-05-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A212942-002	CGT	2021-05-24	`5aa47cf7b7d7…`

Additional Listing Data#

Finished product: Yes
Brand name base: Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TIMOLOL MALEATE	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
313407	Internal RxNorm lookup
313408	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
9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e	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
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
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
273981e4-09e7-45cc-967c-554f628ededf	Product name	3	20230627
97dad5a2-c524-a7b5-dede-82edefe9ce62	Product name	7	20220929
d11e749b-f93e-0ce3-ceda-28fe03d8081d	Product name	2	20190731

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46708-546-05	Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%	5 mL in 1 BOTTLE	SOLUTION/ DROPS	5		1
46708-546-05	Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%	1 in 1 CARTON	SOLUTION/ DROPS	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-546	TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.25% SOLUTION/ DROPS TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.5% SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS LIMITED]	1	Current NDC, 2 package rows	20250427_9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%	TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.25%	Alembic Pharmaceuticals Inc.	b909ecf0-c90a-4719-a144-9e74f457cb87	2025-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212942 application number: ANDA212942
Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%	TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.25%	Alembic Pharmaceuticals Limited	9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e	2025-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212942 application number: ANDA212942 ndc (product): 46708-546

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
313407	timolol maleate 0.25 % Ophthalmic Gel Forming Solution	PSN	9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e	1
313408	timolol maleate 0.5 % Ophthalmic Gel Forming Solution	PSN	9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e	1
313407	timolol 0.0025 MG/MG Ophthalmic Gel	SCD	9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e	1
313408	timolol 0.005 MG/MG Ophthalmic Gel	SCD	9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e	1
313407	timolol 0.25 % Ophthalmic Gel	SY	9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e	1
313407	timolol 0.25 % Ophthalmic Gel Forming Solution	SY	9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e	1
313408	timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic Gel	SY	9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e	1
313408	timolol 0.5 % Gel Forming Ophthalmic Solution	SY	9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
46708-546-05	46708054605	1 BOTTLE in 1 CARTON (46708-546-05) / 5 mL in 1 BOTTLE	1 bottle	2020-11-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.25% and 0.5%	Alembic Pharmaceuticals Limited \| Alembic Pharmaceuticals Limited (F3)	2025-04-25	Human Prescription Drug Label	1