timolol hemihydrate

Generic: timolol hemihydrate

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name timolol hemihydrate
Generic Name timolol hemihydrate
Labeler somerset therapeutics, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

timolol anhydrous 5 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-697
Product ID 70069-697_c1213979-d6ff-44c2-ad97-1de99ddcf8d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216654
Listing Expiration 2026-12-31
Marketing Start 2024-10-31

Pharmacologic Class

Established (EPC)
beta-adrenergic blocker [epc]
Mechanism of Action
adrenergic beta-antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069697
Hyphenated Format 70069-697

Supplemental Identifiers

RxCUI
2702393
UPC
0370069697016 0370069698013 0370069696019
UNII
5JKY92S7BR
NUI
N0000000161 N0000175556

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 hemihydrate (source: ndc)
Generic Name timolol hemihydrate (source: ndc)
Application Number ANDA216654 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70069-697-01) / 10 mL in 1 BOTTLE
source: ndc

Packages (1)

70069-697-01 1 BOTTLE in 1 CARTON (70069-697-01) / 10 mL in 1 BOTTLE

Ingredients (1)

timolol anhydrous (5 mg/mL)

Linked Drug Pages (1)

Timolol Hemihydrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "c1213979-d6ff-44c2-ad97-1de99ddcf8d2", "openfda": {"nui": ["N0000000161", "N0000175556"], "upc": ["0370069697016", "0370069698013", "0370069696019"], "unii": ["5JKY92S7BR"], "rxcui": ["2702393"], "spl_set_id": ["cebc9a5e-0bdb-4f23-9b2c-cde543b62fb6"], "pharm_class_epc": ["beta-Adrenergic Blocker [EPC]"], "pharm_class_moa": ["Adrenergic beta-Antagonists [MoA]"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70069-697-01)  / 10 mL in 1 BOTTLE", "package_ndc": "70069-697-01", "marketing_start_date": "20241031"}], "brand_name": "Timolol Hemihydrate", "product_id": "70069-697_c1213979-d6ff-44c2-ad97-1de99ddcf8d2", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "70069-697", "generic_name": "Timolol Hemihydrate", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Timolol Hemihydrate", "active_ingredients": [{"name": "TIMOLOL ANHYDROUS", "strength": "5 mg/mL"}], "application_number": "ANDA216654", "marketing_category": "ANDA", "marketing_start_date": "20241031", "listing_expiration_date": "20261231"}