alaway

Generic: ketotifen fumarate

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

Drug Facts

Product Profile

Brand Name alaway
Generic Name ketotifen fumarate
Labeler bausch & lomb incorporated
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

ketotifen fumarate .25 mg/mL

Manufacturer
Bausch & Lomb Incorporated

Identifiers & Regulatory

Product NDC 24208-601
Product ID 24208-601_4f27a942-b5f3-4a01-8022-49deced585f8
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021996
Listing Expiration 2026-12-31
Marketing Start 2006-12-01

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24208601
Hyphenated Format 24208-601

Supplemental Identifiers

RxCUI
311237 707594
UNII
HBD503WORO

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 alaway (source: ndc)
Generic Name ketotifen fumarate (source: ndc)
Application Number NDA021996 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .25 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (24208-601-05) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (24208-601-10) / 10 mL in 1 BOTTLE, DROPPER
  • 2 BOTTLE, DROPPER in 1 CARTON (24208-601-90) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (3)

24208-601-05 1 BOTTLE, DROPPER in 1 CARTON (24208-601-05) / 5 mL in 1 BOTTLE, DROPPER 24208-601-10 1 BOTTLE, DROPPER in 1 CARTON (24208-601-10) / 10 mL in 1 BOTTLE, DROPPER 24208-601-90 2 BOTTLE, DROPPER in 1 CARTON (24208-601-90) / 10 mL in 1 BOTTLE, DROPPER

Ingredients (1)

ketotifen fumarate (.25 mg/mL)

Linked Drug Pages (1)

Alaway ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "4f27a942-b5f3-4a01-8022-49deced585f8", "openfda": {"unii": ["HBD503WORO"], "rxcui": ["311237", "707594"], "spl_set_id": ["e4c310b5-1dba-4ddc-bc90-b27ebc765871"], "manufacturer_name": ["Bausch & Lomb Incorporated"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (24208-601-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "24208-601-05", "marketing_start_date": "20061201"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (24208-601-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "24208-601-10", "marketing_start_date": "20061201"}, {"sample": false, "description": "2 BOTTLE, DROPPER in 1 CARTON (24208-601-90)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "24208-601-90", "marketing_start_date": "20061201"}], "brand_name": "Alaway", "product_id": "24208-601_4f27a942-b5f3-4a01-8022-49deced585f8", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Inhibitor [EPC]"], "product_ndc": "24208-601", "generic_name": "Ketotifen Fumarate", "labeler_name": "Bausch & Lomb Incorporated", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Alaway", "active_ingredients": [{"name": "KETOTIFEN FUMARATE", "strength": ".25 mg/mL"}], "application_number": "NDA021996", "marketing_category": "NDA", "marketing_start_date": "20061201", "listing_expiration_date": "20261231"}