tropicamide

Generic: tropicamide

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tropicamide
Generic Name tropicamide
Labeler sandoz inc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

tropicamide 10 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-355
Product ID 61314-355_51620df4-8e34-4ffa-bf5a-077efc3a1911
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084306
Listing Expiration 2026-12-31
Marketing Start 2000-06-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61314355
Hyphenated Format 61314-355

Supplemental Identifiers

RxCUI
314238
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 tropicamide (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, PLASTIC in 1 CARTON (61314-355-01) / 3 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (61314-355-02) / 15 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

61314-355-01 1 BOTTLE, PLASTIC in 1 CARTON (61314-355-01) / 3 mL in 1 BOTTLE, PLASTIC 61314-355-02 1 BOTTLE, PLASTIC in 1 CARTON (61314-355-02) / 15 mL in 1 BOTTLE, PLASTIC

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": "51620df4-8e34-4ffa-bf5a-077efc3a1911", "openfda": {"nui": ["N0000175574", "N0000175370"], "unii": ["N0A3Z5XTC6"], "rxcui": ["314238"], "spl_set_id": ["0104ffe4-013d-4afa-996d-dcba4f08e93d"], "pharm_class_epc": ["Anticholinergic [EPC]"], "pharm_class_moa": ["Cholinergic Antagonists [MoA]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (61314-355-01)  / 3 mL in 1 BOTTLE, PLASTIC", "package_ndc": "61314-355-01", "marketing_start_date": "20000613"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (61314-355-02)  / 15 mL in 1 BOTTLE, PLASTIC", "package_ndc": "61314-355-02", "marketing_start_date": "20000613"}], "brand_name": "Tropicamide", "product_id": "61314-355_51620df4-8e34-4ffa-bf5a-077efc3a1911", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "61314-355", "generic_name": "Tropicamide", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tropicamide", "active_ingredients": [{"name": "TROPICAMIDE", "strength": "10 mg/mL"}], "application_number": "ANDA084306", "marketing_category": "ANDA", "marketing_start_date": "20000613", "listing_expiration_date": "20261231"}