mydriacyl

Generic: tropicamide

Labeler: alcon laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mydriacyl
Generic Name tropicamide
Labeler alcon laboratories, inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

tropicamide 10 mg/mL

Manufacturer
Alcon Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0065-0355
Product ID 0065-0355_3dd122a9-260c-4d25-9f18-38373ce1b07d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084306
Listing Expiration 2026-12-31
Marketing Start 1959-04-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00650355
Hyphenated Format 0065-0355

Supplemental Identifiers

RxCUI
208660 314238
UPC
0300650355032
UNII
N0A3Z5XTC6
NUI
N0000175574 N0000175370

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 mydriacyl (source: ndc)
Generic Name tropicamide (source: ndc)
Application Number ANDA084306 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0065-0355-03) / 3 mL in 1 BOTTLE
source: ndc

Packages (1)

0065-0355-03 1 BOTTLE in 1 CARTON (0065-0355-03) / 3 mL in 1 BOTTLE

Ingredients (1)

tropicamide (10 mg/mL)

Linked Drug Pages (1)

Mydriacyl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "3dd122a9-260c-4d25-9f18-38373ce1b07d", "openfda": {"nui": ["N0000175574", "N0000175370"], "upc": ["0300650355032"], "unii": ["N0A3Z5XTC6"], "rxcui": ["208660", "314238"], "spl_set_id": ["57165763-29dc-4812-b840-a8a5086416f3"], "pharm_class_epc": ["Anticholinergic [EPC]"], "pharm_class_moa": ["Cholinergic Antagonists [MoA]"], "manufacturer_name": ["Alcon Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0065-0355-03)  / 3 mL in 1 BOTTLE", "package_ndc": "0065-0355-03", "marketing_start_date": "19590401"}], "brand_name": "Mydriacyl", "product_id": "0065-0355_3dd122a9-260c-4d25-9f18-38373ce1b07d", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "0065-0355", "generic_name": "tropicamide", "labeler_name": "Alcon Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mydriacyl", "active_ingredients": [{"name": "TROPICAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA084306", "marketing_category": "ANDA", "marketing_start_date": "19590401", "listing_expiration_date": "20261231"}