Tropicamide

Product NDC
61314-354
11-digit product format
613140354
Labeler code
61314
Product ID
61314-354_2fbad93e-d3da-4a31-9a78-66a923ce78ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tropicamide
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
ANDA084305
Marketing category
ANDA
Marketing start
2000-06-09
Substance
TROPICAMIDE
Active strength
5 mg/mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tropicamide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TROPICAMIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN0A3Z5XTC6
Rxcui313521

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
61314-354-01Tropicamide15 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS159
61314-354-01Tropicamide1 in 1 CARTONSOLUTION/ DROPS19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-354-01ML - Milliliter61314-3544f70189e-275a-4ad8-bed6-6bd4d940479012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TROPICAMIDEACTIVE INGREDIENTN0A3Z5XTC6TROPICAMIDE SOLUTION [SANDOZ INC.]3
TROPICAMIDEACTIVE MOIETYN0A3Z5XTC6TROPICAMIDE SOLUTION [SANDOZ INC.]3
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7TROPICAMIDE SOLUTION [SANDOZ INC.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTROPICAMIDE SOLUTION [SANDOZ INC.]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBTROPICAMIDE SOLUTION [SANDOZ INC.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTROPICAMIDE SOLUTION [SANDOZ INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITROPICAMIDE SOLUTION [SANDOZ INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RTROPICAMIDE SOLUTION [SANDOZ INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-354TROPICAMIDE SOLUTION/ DROPS [SANDOZ INC]9Current NDC, Legacy NDC, 2 package rows20220309_521592d1-53a1-4314-8b3f-d808f3bccfcd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313521tropicamide 0.5 % Ophthalmic SolutionPSN521592d1-53a1-4314-8b3f-d808f3bccfcd9
313521tropicamide 5 MG/ML Ophthalmic SolutionSCD521592d1-53a1-4314-8b3f-d808f3bccfcd9
313521tropicamide 0.5 % Ophthalmic SolutionSY521592d1-53a1-4314-8b3f-d808f3bccfcd9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61314-354-01613140354011 BOTTLE, PLASTIC in 1 CARTON (61314-354-01) / 15 mL in 1 BOTTLE, PLASTIC2000-06-090000-00-00NoNoCurrent