tropicamide

Generic: tropicamide

Labeler: sportpharm llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tropicamide
Generic Name tropicamide
Labeler sportpharm llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

tropicamide 10 mg/mL

Manufacturer
Sportpharm LLC

Identifiers & Regulatory

Product NDC 85766-040
Product ID 85766-040_4a2ba794-da99-91aa-e063-6394a90a8370
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207524
Listing Expiration 2027-12-31
Marketing Start 2019-12-12

Pharmacologic Class

Established (EPC)
anticholinergic [epc]
Mechanism of Action
cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85766040
Hyphenated Format 85766-040

Supplemental Identifiers

RxCUI
314238
UNII
N0A3Z5XTC6
NUI
N0000175574 N0000175370

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 tropicamide (source: ndc)
Generic Name tropicamide (source: ndc)
Application Number ANDA207524 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (85766-040-15) / 15 mL in 1 BOTTLE
source: ndc

Packages (1)

85766-040-15 1 BOTTLE in 1 CARTON (85766-040-15) / 15 mL in 1 BOTTLE

Ingredients (1)

tropicamide (10 mg/mL)

Linked Drug Pages (1)

Tropicamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "4a2ba794-da99-91aa-e063-6394a90a8370", "openfda": {"nui": ["N0000175574", "N0000175370"], "unii": ["N0A3Z5XTC6"], "rxcui": ["314238"], "spl_set_id": ["fc62f539-6478-4740-98ed-5e27fcfa794e"], "pharm_class_epc": ["Anticholinergic [EPC]"], "pharm_class_moa": ["Cholinergic Antagonists [MoA]"], "manufacturer_name": ["Sportpharm LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (85766-040-15)  / 15 mL in 1 BOTTLE", "package_ndc": "85766-040-15", "marketing_start_date": "20250807"}], "brand_name": "Tropicamide", "product_id": "85766-040_4a2ba794-da99-91aa-e063-6394a90a8370", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "85766-040", "generic_name": "Tropicamide", "labeler_name": "Sportpharm LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tropicamide", "active_ingredients": [{"name": "TROPICAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA207524", "marketing_category": "ANDA", "marketing_start_date": "20191212", "listing_expiration_date": "20271231"}