istalol

Generic: timolol maleate

Labeler: bausch & lomb incorporated
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name istalol
Generic Name timolol maleate
Labeler bausch & lomb incorporated
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 5 mg/mL

Manufacturer
Bausch & Lomb Incorporated

Identifiers & Regulatory

Product NDC 24208-004
Product ID 24208-004_25b64789-6ef9-4c49-e063-6294a90a0ec4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021516
Listing Expiration 2026-12-31
Marketing Start 2004-08-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24208004
Hyphenated Format 24208-004

Supplemental Identifiers

RxCUI
1992299 1992300
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 istalol (source: ndc)
Generic Name timolol maleate (source: ndc)
Application Number NDA021516 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (24208-004-01) / 2.5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (24208-004-02) / 2.5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (24208-004-03) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (3)

24208-004-01 1 BOTTLE, DROPPER in 1 CARTON (24208-004-01) / 2.5 mL in 1 BOTTLE, DROPPER 24208-004-02 1 BOTTLE, DROPPER in 1 CARTON (24208-004-02) / 2.5 mL in 1 BOTTLE, DROPPER 24208-004-03 1 BOTTLE, DROPPER in 1 CARTON (24208-004-03) / 5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

timolol maleate (5 mg/mL)

Linked Drug Pages (1)

Istalol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "25b64789-6ef9-4c49-e063-6294a90a0ec4", "openfda": {"unii": ["P8Y54F701R"], "rxcui": ["1992299", "1992300"], "spl_set_id": ["258bbc8d-00ee-45b0-ac35-6f16c4e8d45f"], "manufacturer_name": ["Bausch & Lomb Incorporated"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (24208-004-01)  / 2.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "24208-004-01", "marketing_start_date": "20040802"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (24208-004-02)  / 2.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "24208-004-02", "marketing_start_date": "20040802"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (24208-004-03)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "24208-004-03", "marketing_start_date": "20040802"}], "brand_name": "Istalol", "product_id": "24208-004_25b64789-6ef9-4c49-e063-6294a90a0ec4", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "24208-004", "generic_name": "Timolol Maleate", "labeler_name": "Bausch & Lomb Incorporated", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Istalol", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "NDA021516", "marketing_category": "NDA", "marketing_start_date": "20040802", "listing_expiration_date": "20261231"}