tropicamide

Generic: tropicamide

Labeler: asclemed usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tropicamide
Generic Name tropicamide
Labeler asclemed usa inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

tropicamide 10 mg/mL

Manufacturer
ASCLEMED USA INC.

Identifiers & Regulatory

Product NDC 76420-438
Product ID 76420-438_3c135180-271c-9a2b-e063-6294a90a0164
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207524
Listing Expiration 2026-12-31
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 76420438
Hyphenated Format 76420-438

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 (76420-438-15) / 15 mL in 1 BOTTLE
source: ndc

Packages (1)

76420-438-15 1 BOTTLE in 1 CARTON (76420-438-15) / 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": "3c135180-271c-9a2b-e063-6294a90a0164", "openfda": {"nui": ["N0000175574", "N0000175370"], "unii": ["N0A3Z5XTC6"], "rxcui": ["314238"], "spl_set_id": ["f24c19cf-c14a-4a9f-a3b0-49a22e4faa32"], "pharm_class_epc": ["Anticholinergic [EPC]"], "pharm_class_moa": ["Cholinergic Antagonists [MoA]"], "manufacturer_name": ["ASCLEMED USA INC."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (76420-438-15)  / 15 mL in 1 BOTTLE", "package_ndc": "76420-438-15", "marketing_start_date": "20250807"}], "brand_name": "Tropicamide", "product_id": "76420-438_3c135180-271c-9a2b-e063-6294a90a0164", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "76420-438", "generic_name": "Tropicamide", "labeler_name": "ASCLEMED USA INC.", "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": "20261231"}