betimol

Generic: timolol

Labeler: thea pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name betimol
Generic Name timolol
Labeler thea pharma inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

timolol 2.56 mg/mL

Manufacturer
Thea Pharma Inc.

Identifiers & Regulatory

Product NDC 82584-001
Product ID 82584-001_3891d7f3-d858-9f71-e063-6394a90af95b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020439
Listing Expiration 2026-12-31
Marketing Start 2022-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82584001
Hyphenated Format 82584-001

Supplemental Identifiers

RxCUI
208560 1992305 2702393 2702398
UPC
0382584002053
UNII
817W3C6175

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 betimol (source: ndc)
Generic Name timolol (source: ndc)
Application Number NDA020439 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2.56 mg/mL
source: ndc
Packaging
  • HOW SUPPLIED Betimol ® (timolol ophthalmic solution) is a clear, colorless solution. Betimol ® 0.25% is supplied in a white, opaque, plastic, ophthalmic dispenser bottle with a controlled drop tip as follows: NDC 82584-001-05 5 mL fill in 5 cc container Betimol ® 0.5% is supplied in a white, opaque, plastic, ophthalmic dispenser bottle with a controlled drop tip as follows: NDC 82584-002-05 5 mL fill in 5 cc container NDC 82584-002-15 15 mL fill in 15 cc container Rx Only STORAGE Store between 15° to 25°C (59° to 77°F). Do not freeze. Protect from light.
  • PRINCIPAL DISPLAY PANEL - 5 mL Bottle Carton NDC 82584-001-05 BETIMOL ® (timolol ophthalmic solution) 0.25% Timolol equivalent (timolol hemihydrate 2.56 mg/mL) Rx Only 5 mL Betimol 0.25%
  • PRINCIPAL DISPLAY PANEL - 5 mL Bottle Carton - NDC 82854-002-05 NDC 82584-002-05 BETIMOL ® (timolol ophthalmic solution) 0.5% Timolol equivalent (timolol hemihydrate 5.12 mg/mL) Rx Only 5 mL Betimol 0.5%
source: label

Packages (0)

No package records.

Ingredients (1)

timolol (2.56 mg/mL)

Linked Drug Pages (1)

BETIMOL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "3891d7f3-d858-9f71-e063-6394a90af95b", "openfda": {"upc": ["0382584002053"], "unii": ["817W3C6175"], "rxcui": ["208560", "1992305", "2702393", "2702398"], "spl_set_id": ["3ae775f4-340c-4bf4-aa49-8a31daba0f8b"], "manufacturer_name": ["Thea Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "BETIMOL", "product_id": "82584-001_3891d7f3-d858-9f71-e063-6394a90af95b", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "82584-001", "generic_name": "timolol", "labeler_name": "Thea Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BETIMOL", "active_ingredients": [{"name": "TIMOLOL", "strength": "2.56 mg/mL"}], "application_number": "NDA020439", "marketing_category": "NDA", "marketing_start_date": "20221201", "listing_expiration_date": "20261231"}