timoptic in ocudose

Generic: timolol maleate

Labeler: nordic pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name timoptic in ocudose
Generic Name timolol maleate
Labeler nordic pharma, inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

timolol maleate 5 mg/mL

Manufacturer
Nordic Pharma, Inc.

Identifiers & Regulatory

Product NDC 69918-601
Product ID 69918-601_568ed4c4-e34b-4dda-a1ff-8d9fcf9ff502
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212592
Listing Expiration 2026-12-31
Marketing Start 2022-02-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69918601
Hyphenated Format 69918-601

Supplemental Identifiers

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 timoptic in ocudose (source: ndc)
Generic Name timolol maleate (source: ndc)
Application Number ANDA212592 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 60 POUCH in 1 CARTON (69918-601-60) / 10 CONTAINER in 1 POUCH / .3 mL in 1 CONTAINER
source: ndc

Packages (1)

69918-601-60 60 POUCH in 1 CARTON (69918-601-60) / 10 CONTAINER in 1 POUCH / .3 mL in 1 CONTAINER

Ingredients (1)

timolol maleate (5 mg/mL)

Linked Drug Pages (1)

Timoptic in Ocudose ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "568ed4c4-e34b-4dda-a1ff-8d9fcf9ff502", "openfda": {"unii": ["P8Y54F701R"], "spl_set_id": ["16323b0e-78ae-40e5-be93-04f698dd672b"], "manufacturer_name": ["Nordic Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 POUCH in 1 CARTON (69918-601-60)  / 10 CONTAINER in 1 POUCH / .3 mL in 1 CONTAINER", "package_ndc": "69918-601-60", "marketing_start_date": "20220226"}], "brand_name": "Timoptic in Ocudose", "product_id": "69918-601_568ed4c4-e34b-4dda-a1ff-8d9fcf9ff502", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "69918-601", "generic_name": "Timolol Maleate", "labeler_name": "Nordic Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Timoptic in Ocudose", "active_ingredients": [{"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA212592", "marketing_category": "ANDA", "marketing_start_date": "20220226", "listing_expiration_date": "20261231"}