timolol maleate ophthalmic gel forming solution 0.5%

Generic: timolol maleate ophthalmic gel forming solution 0.5%

Labeler: dr. reddy's laboratories, inc.
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 dr. reddy's laboratories, inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 5 mg/mL

Manufacturer
Dr. Reddy's Laboratories, Inc.

Identifiers & Regulatory

Product NDC 43598-748
Product ID 43598-748_bc484449-5dbd-e029-8a18-10c5af1205a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215733
Listing Expiration 2026-12-31
Marketing Start 2022-11-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598748
Hyphenated Format 43598-748

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 ANDA215733 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (43598-748-11) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

43598-748-11 1 BOTTLE in 1 CARTON (43598-748-11) / 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": "bc484449-5dbd-e029-8a18-10c5af1205a0", "openfda": {"unii": ["P8Y54F701R"], "rxcui": ["313407", "313408"], "spl_set_id": ["d987fdfa-3643-aa1d-cacd-c4f95f192ce7"], "manufacturer_name": ["Dr. Reddy's Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (43598-748-11)  / 5 mL in 1 BOTTLE", "package_ndc": "43598-748-11", "marketing_start_date": "20221115"}], "brand_name": "Timolol Maleate Ophthalmic Gel Forming Solution 0.5%", "product_id": "43598-748_bc484449-5dbd-e029-8a18-10c5af1205a0", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "43598-748", "generic_name": "Timolol Maleate Ophthalmic Gel Forming Solution 0.5%", "labeler_name": "Dr. Reddy's Laboratories, Inc.", "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": "ANDA215733", "marketing_category": "ANDA", "marketing_start_date": "20221115", "listing_expiration_date": "20261231"}