FDA.reportPublic FDA data

Trospium Chloride

Product NDC
70518-4593
11-digit product format
705184593
Labeler code
70518
Product ID
70518-4593_502530ff-ea3c-2d59-e063-6394a90a3345
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trospium Chloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204945
Marketing category
ANDA
Marketing start
2026-03-23
Substance
TROSPIUM CHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic 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
Trospium Chloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TROSPIUM CHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1E6682427E
Rxcui857560

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
70518-4593-0Trospium Chloride30 in 1 BOXTABLET, FILM COATED304
70518-4593-1Trospium Chloride1 in 1 POUCHTABLET, FILM COATED14
70518-4593-2Trospium Chloride60 in 1 BOXTABLET, FILM COATED604
70518-4593-3Trospium Chloride100 in 1 BOXTABLET, FILM COATED1004
70518-4593-4Trospium Chloride50 in 1 BOXTABLET, FILM COATED504

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857560trospium chloride 20 MG Oral TabletPSN48d1b484-ee0a-4d66-9b45-4ba34e65ed134
857560trospium chloride 20 MG Oral TabletSCD48d1b484-ee0a-4d66-9b45-4ba34e65ed134

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4593-07051845930030 POUCH in 1 BOX (70518-4593-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4593-1) 30 pouch2026-03-23NoNoHistorical
70518-4593-1705184593011 in 1 POUCHHistorical
70518-4593-27051845930260 POUCH in 1 BOX (70518-4593-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-4593-1) 60 pouch2026-04-01NoNoHistorical
70518-4593-370518459303100 POUCH in 1 BOX (70518-4593-3) / 1 TABLET, FILM COATED in 1 POUCH (70518-4593-1) 100 pouch2026-04-06NoNoHistorical
70518-4593-47051845930450 POUCH in 1 BOX (70518-4593-4) / 1 TABLET, FILM COATED in 1 POUCH (70518-4593-1) 50 pouch2026-04-23NoNoHistorical