Tropicamide

Product NDC
76420-438
11-digit product format
764200438
Labeler code
76420
Product ID
76420-438_3c135180-271c-9a2b-e063-6294a90a0164
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tropicamide
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
ASCLEMED USA INC.
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
2026-12-31
Current FDA listing
Yes

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
76420-438-15Tropicamide15 mL in 1 BOTTLESOLUTION/ DROPS151
76420-438-15Tropicamide1 in 1 CARTONSOLUTION/ DROPS11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-438-15764200438151 BOTTLE in 1 CARTON (76420-438-15) / 15 mL in 1 BOTTLE1 bottle2025-08-07NoNoHistorical