TROSPIUM CHLORIDE

Product NDC
68001-427
11-digit product format
680010427
Labeler code
68001
Product ID
68001-427_ed27c30d-c83a-45af-9c47-807da858d696
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TROSPIUM CHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bluepoint Laboratories
Application
ANDA213185
Marketing category
ANDA
Marketing start
2020-07-10
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
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
68001-427-04TROSPIUM CHLORIDE30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-427-04EA - Each68001-427f20f700a-4200-4ced-a26b-cae5a237187412020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-427TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [BLUEPOINT LABORATORIES]1Current NDC, Legacy NDC, 1 package rows20200710_ed27c30d-c83a-45af-9c47-807da858d696.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857564trospium chloride 60 MG 24HR Extended Release Oral CapsulePSNed27c30d-c83a-45af-9c47-807da858d6961
85756424 HR trospium chloride 60 MG Extended Release Oral CapsuleSCDed27c30d-c83a-45af-9c47-807da858d6961
857564trospium chloride 60 MG 24 HR Extended Release Oral CapsuleSYed27c30d-c83a-45af-9c47-807da858d6961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-427-046800104270430 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68001-427-04) 2020-07-100000-00-00NoNoCurrent