betoptic s

Generic: betaxolol hydrochloride

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name betoptic s
Generic Name betaxolol hydrochloride
Labeler novartis pharmaceuticals corporation
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

betaxolol hydrochloride 2.8 mg/mL

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0729
Product ID 0078-0729_c0cc485e-81d4-4204-a894-caa615bea90b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019845
Marketing Start 1996-01-15
Marketing End 2026-11-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780729
Hyphenated Format 0078-0729

Supplemental Identifiers

RxCUI
213729 308719
UNII
6X97D2XT0O

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 betoptic s (source: ndc)
Generic Name betaxolol hydrochloride (source: ndc)
Application Number NDA019845 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2.8 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0078-0729-10) / 10 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0078-0729-15) / 15 mL in 1 BOTTLE
source: ndc

Packages (2)

0078-0729-10 1 BOTTLE in 1 CARTON (0078-0729-10) / 10 mL in 1 BOTTLE 0078-0729-15 1 BOTTLE in 1 CARTON (0078-0729-15) / 15 mL in 1 BOTTLE

Ingredients (1)

betaxolol hydrochloride (2.8 mg/mL)

Linked Drug Pages (1)

Betoptic S ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "c0cc485e-81d4-4204-a894-caa615bea90b", "openfda": {"unii": ["6X97D2XT0O"], "rxcui": ["213729", "308719"], "spl_set_id": ["905ba189-456c-4aa4-8231-39a971374ad8"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0078-0729-10)  / 10 mL in 1 BOTTLE", "package_ndc": "0078-0729-10", "marketing_end_date": "20261130", "marketing_start_date": "20220803"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0078-0729-15)  / 15 mL in 1 BOTTLE", "package_ndc": "0078-0729-15", "marketing_end_date": "20261130", "marketing_start_date": "20220803"}], "brand_name": "Betoptic S", "product_id": "0078-0729_c0cc485e-81d4-4204-a894-caa615bea90b", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "0078-0729", "generic_name": "betaxolol hydrochloride", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Betoptic S", "active_ingredients": [{"name": "BETAXOLOL HYDROCHLORIDE", "strength": "2.8 mg/mL"}], "application_number": "NDA019845", "marketing_category": "NDA", "marketing_end_date": "20261130", "marketing_start_date": "19960115"}