Trospium Chloride

Product NDC
63629-8458
11-digit product format
636298458
Labeler code
63629
Product ID
63629-8458_92fd6281-041a-461a-902d-e42f4b8821ed
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
63629-8458-1Trospium ChlorideER30 in 1 BOTTLECAPSULE, EXTENDED RELEASE30105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8458-1EA - Each63629-8458ccbcdd8c-1038-48fb-8e6c-c70d1173b90812021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8458TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 1 package rows20240918_2f431dd1-e130-45e5-a796-1662f498585e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857564trospium chloride 60 MG 24HR Extended Release Oral CapsulePSN2f431dd1-e130-45e5-a796-1662f498585e105
85756424 HR trospium chloride 60 MG Extended Release Oral CapsuleSCD2f431dd1-e130-45e5-a796-1662f498585e105
857564trospium chloride 60 MG 24 HR Extended Release Oral CapsuleSY2f431dd1-e130-45e5-a796-1662f498585e105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8458-16362984580130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8458-1) 2022-02-090000-00-00NoNoCurrent