betaxolol hydrochloride

Generic: betaxolol hydrochloride

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name betaxolol hydrochloride
Generic Name betaxolol hydrochloride
Labeler sandoz inc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

betaxolol hydrochloride 5.6 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-245
Product ID 61314-245_c30e555b-1a79-4c3e-b79d-8c1d950fd832
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA019270
Listing Expiration 2026-12-31
Marketing Start 2000-05-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61314245
Hyphenated Format 61314-245

Supplemental Identifiers

RxCUI
308720
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 betaxolol hydrochloride (source: ndc)
Generic Name betaxolol hydrochloride (source: ndc)
Application Number NDA019270 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5.6 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (61314-245-01) / 5 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (61314-245-02) / 15 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (61314-245-03) / 10 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (3)

61314-245-01 1 BOTTLE, PLASTIC in 1 CARTON (61314-245-01) / 5 mL in 1 BOTTLE, PLASTIC 61314-245-02 1 BOTTLE, PLASTIC in 1 CARTON (61314-245-02) / 15 mL in 1 BOTTLE, PLASTIC 61314-245-03 1 BOTTLE, PLASTIC in 1 CARTON (61314-245-03) / 10 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

betaxolol hydrochloride (5.6 mg/mL)

Linked Drug Pages (1)

Betaxolol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "c30e555b-1a79-4c3e-b79d-8c1d950fd832", "openfda": {"unii": ["6X97D2XT0O"], "rxcui": ["308720"], "spl_set_id": ["a73519d5-546c-4377-92ed-0d4be2685d60"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (61314-245-01)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "61314-245-01", "marketing_start_date": "20000515"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (61314-245-02)  / 15 mL in 1 BOTTLE, PLASTIC", "package_ndc": "61314-245-02", "marketing_start_date": "20000515"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (61314-245-03)  / 10 mL in 1 BOTTLE, PLASTIC", "package_ndc": "61314-245-03", "marketing_start_date": "20000515"}], "brand_name": "Betaxolol Hydrochloride", "product_id": "61314-245_c30e555b-1a79-4c3e-b79d-8c1d950fd832", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "61314-245", "generic_name": "Betaxolol Hydrochloride", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Betaxolol Hydrochloride", "active_ingredients": [{"name": "BETAXOLOL HYDROCHLORIDE", "strength": "5.6 mg/mL"}], "application_number": "NDA019270", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20000515", "listing_expiration_date": "20261231"}