timolol maleate ophthalmic gel forming solution, 0.5%

Generic: timolol maleate ophthalmic gel forming solution, 0.5%

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name timolol maleate ophthalmic gel forming solution, 0.5%
Generic Name timolol maleate ophthalmic gel forming solution, 0.5%
Labeler alembic pharmaceuticals limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 5 mg/mL

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-546
Product ID 46708-546_9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212942
Listing Expiration 2026-12-31
Marketing Start 2020-11-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708546
Hyphenated Format 46708-546

Supplemental Identifiers

RxCUI
313407 313408
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, 0.5% (source: ndc)
Generic Name timolol maleate ophthalmic gel forming solution, 0.5% (source: ndc)
Application Number ANDA212942 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (46708-546-05) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

46708-546-05 1 BOTTLE in 1 CARTON (46708-546-05) / 5 mL in 1 BOTTLE

Ingredients (1)

timolol maleate (5 mg/mL)

Linked Drug Pages (1)

Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%, Timolol Maleate Ophthalmic Gel Forming Solution, 0.5% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e", "openfda": {"unii": ["P8Y54F701R"], "rxcui": ["313407", "313408"], "spl_set_id": ["9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (46708-546-05)  / 5 mL in 1 BOTTLE", "package_ndc": "46708-546-05", "marketing_start_date": "20201122"}], "brand_name": "Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%", "product_id": "46708-546_9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "46708-546", "generic_name": "Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA212942", "marketing_category": "ANDA", "marketing_start_date": "20201122", "listing_expiration_date": "20261231"}