Timolol Maleate

Product NDC: 42571-404
11-digit product format: 425710404
Labeler code: 42571
Product ID: 42571-404_238fd036-1868-da83-e063-6394a90a0596
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Timolol Maleate Ophthalmic
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Micro Labs Limited
Application: ANDA217343
Marketing category: ANDA
Marketing start: 2023-08-01
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

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
TIMOLOL MALEATE	5 mg/mL

Field, Values table
Field	Values
Unii	P8Y54F701R
Rxcui	1923428, 1992303

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
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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42571-404-21	Timolol Maleate	5 mL in 1 BOTTLE	SOLUTION/ DROPS	5		4
42571-404-88	Timolol Maleate	10 mL in 1 BOTTLE	SOLUTION/ DROPS	10		4

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42571-404-21	ML - Milliliter	42571-404	873aeb92-1934-4e5e-9783-507e527eaa92	1	2025-02-10
42571-404-88	ML - Milliliter	42571-404	6be9ffc9-56ca-4654-96d6-7450a9429921	1	2025-02-10

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-404	TIMOLOL MALEATE (TIMOLOL MALEATE OPHTHALMIC) SOLUTION/ DROPS [MICRO LABS LIMITED]	4	Current NDC, 2 package rows	20241004_6c9f3971-8c07-4d3a-915d-76438baa2a0b.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1992303	timolol 0.5 % 12HR Ophthalmic Solution	PSN	6c9f3971-8c07-4d3a-915d-76438baa2a0b	4
1923428	timolol maleate 0.25 % Ophthalmic Solution	PSN	6c9f3971-8c07-4d3a-915d-76438baa2a0b	4
1992303	12 HR timolol 5 MG/ML Ophthalmic Solution	SCD	6c9f3971-8c07-4d3a-915d-76438baa2a0b	4
1923428	timolol 2.5 MG/ML Ophthalmic Solution	SCD	6c9f3971-8c07-4d3a-915d-76438baa2a0b	4
1923428	timolol 0.25 % Ophthalmic Solution	SY	6c9f3971-8c07-4d3a-915d-76438baa2a0b	4
1992303	timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic Solution	SY	6c9f3971-8c07-4d3a-915d-76438baa2a0b	4
1992303	timolol 0.5 % 12 HR Ophthalmic Solution	SY	6c9f3971-8c07-4d3a-915d-76438baa2a0b	4
1923428	timolol 2.5 MG/ML (as timolol maleate 3.4 MG/ML) Ophthalmic Solution	SY	6c9f3971-8c07-4d3a-915d-76438baa2a0b	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42571-404-21	42571040421	5 mL in 1 BOTTLE (42571-404-21)	5 ml	2023-08-01	No	No	Current
42571-404-88	42571040488	10 mL in 1 BOTTLE (42571-404-88)	10 ml	2023-08-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% Rx Only	Micro Labs Limited	2024-10-03	HUMAN PRESCRIPTION DRUG LABEL	4