Tropicamide

Product NDC
85766-040
11-digit product format
857660040
Labeler code
85766
Product ID
85766-040_4a2ba794-da99-91aa-e063-6394a90a8370
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tropicamide
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Sportpharm LLC
Application
ANDA207524
Marketing category
ANDA
Marketing start
2019-12-12
Substance
TROPICAMIDE
Active strength
10 mg/mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tropicamide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TROPICAMIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN0A3Z5XTC6
Rxcui314238

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
6e36a95f-fcff-e2d1-3f9b-17d0b7f9e28cProduct name220200603
41722ce4-2429-80d8-5977-d735f8eca6d6Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85766-040-15Tropicamide15 mL in 1 BOTTLESOLUTION/ DROPS152
85766-040-15Tropicamide1 in 1 CARTONSOLUTION/ DROPS12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314238tropicamide 1 % Ophthalmic SolutionPSNfc62f539-6478-4740-98ed-5e27fcfa794e2
314238tropicamide 10 MG/ML Ophthalmic SolutionSCDfc62f539-6478-4740-98ed-5e27fcfa794e2
314238tropicamide 1 % Ophthalmic SolutionSYfc62f539-6478-4740-98ed-5e27fcfa794e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-040-15857660040151 BOTTLE in 1 CARTON (85766-040-15) / 15 mL in 1 BOTTLE1 bottle2025-08-07NoNoCurrent