FDA.reportPublic FDA data

Trospium Chloride

Product NDC
72162-1106
11-digit product format
721621106
Labeler code
72162
Product ID
72162-1106_849b6114-1cf2-4e15-a3aa-01abd680a6af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trospium Chloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201291
Marketing category
ANDA
Marketing start
2013-06-07
Substance
TROSPIUM CHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic 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
Trospium Chloride
Brand name suffix
ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TROSPIUM CHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1E6682427E
Rxcui857564

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bfc41181-d174-476d-8a52-4a385ae9213dProduct name120250423
7c473500-2ad1-88f9-e10e-6f8136eda28cProduct name420250226
9151f483-8353-9cd4-427d-86fb1b5ba7eaProduct name420211027

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1106-1Trospium ChlorideER100 in 1 BOTTLECAPSULE, EXTENDED RELEASE100102
72162-1106-3Trospium ChlorideER30 in 1 BOTTLECAPSULE, EXTENDED RELEASE30102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1106-1EA - Each72162-1106665ffa52-76a0-4a37-b1a3-7ed71f52271012024-08-12
72162-1106-3EA - Each72162-11061364eece-3bd3-4526-8fc6-cbf6629b087312024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1106TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20240718_dfc1af0b-b0e7-43fd-8da0-65281963bc3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857564trospium chloride 60 MG 24HR Extended Release Oral CapsulePSNdfc1af0b-b0e7-43fd-8da0-65281963bc3e102
85756424 HR trospium chloride 60 MG Extended Release Oral CapsuleSCDdfc1af0b-b0e7-43fd-8da0-65281963bc3e102
857564trospium chloride 60 MG 24 HR Extended Release Oral CapsuleSYdfc1af0b-b0e7-43fd-8da0-65281963bc3e102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1106-172162110601100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1106-1) 2023-09-13NoNoHistorical
72162-1106-37216211060330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1106-3) 2023-09-13NoNoHistorical