timolol maleate ophthalmic gel forming solution

Generic: timolol maleate ophthalmic gel forming

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name timolol maleate ophthalmic gel forming solution
Generic Name timolol maleate ophthalmic gel forming
Labeler gland pharma limited
Dosage Form SOLUTION, GEL FORMING / DROPS
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 5 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-458
Product ID 68083-458_0c73f98d-4f49-415a-abc5-2d253061e669
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214645
Listing Expiration 2026-12-31
Marketing Start 2023-02-14

Pharmacologic Class

Classes
adrenergic beta-antagonists [moa] beta-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083458
Hyphenated Format 68083-458

Supplemental Identifiers

RxCUI
313407 313408
UPC
0368083457013
UNII
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 timolol maleate ophthalmic gel forming solution (source: ndc)
Generic Name timolol maleate ophthalmic gel forming (source: ndc)
Application Number ANDA214645 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68083-458-01) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

68083-458-01 1 BOTTLE in 1 CARTON (68083-458-01) / 5 mL in 1 BOTTLE

Ingredients (1)

timolol maleate (5 mg/mL)

Linked Drug Pages (1)

timolol maleate ophthalmic gel forming solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "0c73f98d-4f49-415a-abc5-2d253061e669", "openfda": {"upc": ["0368083457013"], "unii": ["P8Y54F701R"], "rxcui": ["313407", "313408"], "spl_set_id": ["79730e4f-d533-42c7-b7b6-cdbc47242baa"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68083-458-01)  / 5 mL in 1 BOTTLE", "package_ndc": "68083-458-01", "marketing_start_date": "20230214"}], "brand_name": "timolol maleate ophthalmic gel forming solution", "product_id": "68083-458_0c73f98d-4f49-415a-abc5-2d253061e669", "dosage_form": "SOLUTION, GEL FORMING / DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "68083-458", "generic_name": "timolol maleate ophthalmic gel forming", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "timolol maleate ophthalmic gel forming solution", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA214645", "marketing_category": "ANDA", "marketing_start_date": "20230214", "listing_expiration_date": "20261231"}