Dorzolamide Hydrochloride and Timolol Maleate

Product NDC: 50090-6371
11-digit product format: 500906371
Labeler code: 50090
Product ID: 50090-6371_0e21f8dd-6fb3-4150-a6c0-a9c20aee8fdf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dorzolamide Hydrochloride and Timolol Maleate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: A-S Medication Solutions
Application: ANDA090037
Marketing category: ANDA
Marketing start: 2009-07-14
Substance: DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Active strength: 20; 5 mg/mL; mg/mL
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 50090-6371_0e21f8dd-6fb3-4150-a6c0-a9c20aee8fdf
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Dorzolamide Hydrochloride and Timolol Maleate
Generic name: Dorzolamide Hydrochloride and Timolol Maleate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Marketing start: 2009-07-14
Marketing category: ANDA
Application number: ANDA090037
Pharmacologic classes: Adrenergic beta-Antagonists [MoA]; Carbonic Anhydrase Inhibitor [EPC]; Carbonic Anhydrase Inhibitors [MoA]; beta-Adrenergic Blocker [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
DORZOLAMIDE HYDROCHLORIDE	20 mg/mL
TIMOLOL MALEATE	5 mg/mL

UNII	Preferred term	Registry number	Matched term
QZO5366EW7	DORZOLAMIDE HYDROCHLORIDE	130693-82-2	DORZOLAMIDE HYDROCHLORIDE
P8Y54F701R	TIMOLOL MALEATE	26921-17-5	TIMOLOL MALEATE

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-6371-0	50090637100	1 BOTTLE, DROPPER in 1 CARTON (50090-6371-0) / 10 mL in 1 BOTTLE, DROPPER	2023-02-13	No	No	Current

Title	Manufacturer	Effective date	Type	Version
Dorzolamide Hydrochloride and Timolol Maleate	A-S Medication Solutions	2024-11-01	HUMAN PRESCRIPTION DRUG LABEL	3