dorzolamide hydrochloride timolol maletae

Generic: ddorzolamide hydrochloride timolol maleate

Labeler: indoco remedies limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dorzolamide hydrochloride timolol maletae
Generic Name ddorzolamide hydrochloride timolol maleate
Labeler indoco remedies limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

dorzolamide hydrochloride 20 mg/mL, timolol maleate 5 mg/mL

Manufacturer
Indoco Remedies Limited

Identifiers & Regulatory

Product NDC 14445-405
Product ID 14445-405_930864c1-40f8-45ea-aa4f-c158b3d9f53d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202054
Listing Expiration 2027-12-31
Marketing Start 2021-05-14

Pharmacologic Class

Classes
adrenergic beta-antagonists [moa] carbonic anhydrase inhibitor [epc] carbonic anhydrase inhibitors [moa] beta-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 14445405
Hyphenated Format 14445-405

Supplemental Identifiers

RxCUI
1923432
UPC
0314445405109
UNII
QZO5366EW7 P8Y54F701R

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dorzolamide hydrochloride timolol maletae (source: ndc)
Generic Name ddorzolamide hydrochloride timolol maleate (source: ndc)
Application Number ANDA202054 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DISPENSING in 1 CARTON (14445-405-10) / 10 mL in 1 BOTTLE, DISPENSING
source: ndc

Packages (1)

14445-405-10 1 BOTTLE, DISPENSING in 1 CARTON (14445-405-10) / 10 mL in 1 BOTTLE, DISPENSING

Ingredients (2)

dorzolamide hydrochloride (20 mg/mL) timolol maleate (5 mg/mL)

Linked Drug Pages (1)

DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "930864c1-40f8-45ea-aa4f-c158b3d9f53d", "openfda": {"upc": ["0314445405109"], "unii": ["QZO5366EW7", "P8Y54F701R"], "rxcui": ["1923432"], "spl_set_id": ["0b75a79a-e048-4bf1-b02b-a72a8b8a0b3b"], "manufacturer_name": ["Indoco Remedies Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DISPENSING in 1 CARTON (14445-405-10)  / 10 mL in 1 BOTTLE, DISPENSING", "package_ndc": "14445-405-10", "marketing_start_date": "20210514"}], "brand_name": "DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAE", "product_id": "14445-405_930864c1-40f8-45ea-aa4f-c158b3d9f53d", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "14445-405", "generic_name": "ddorzolamide hydrochloride timolol maleate", "labeler_name": "Indoco Remedies Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAE", "active_ingredients": [{"name": "DORZOLAMIDE HYDROCHLORIDE", "strength": "20 mg/mL"}, {"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA202054", "marketing_category": "ANDA", "marketing_start_date": "20210514", "listing_expiration_date": "20271231"}