TROSPIUM CHLORIDE

Product NDC
70436-174
11-digit product format
704360174
Labeler code
70436
Product ID
70436-174_5239fab8-ae30-29ec-e063-6294a90a1531
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TROSPIUM CHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA214760
Marketing category
ANDA
Marketing start
2021-06-21
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
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 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9151f483-8353-9cd4-427d-86fb1b5ba7eaProduct name420211027
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70436-174-04TROSPIUM CHLORIDE30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-174-04EA - Each70436-1746a78ae3f-1354-40bb-b6f0-7ebe9fc570dd12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-174TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [SLATE RUN PHARMACEUTICALS, LLC]11Current NDC, Legacy NDC, 1 package rows20240621_c1c8bd8b-7ff8-5940-e053-2995a90ae656.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857564trospium chloride 60 MG 24HR Extended Release Oral CapsulePSNc1c8bd8b-7ff8-5940-e053-2995a90ae65613
85756424 HR trospium chloride 60 MG Extended Release Oral CapsuleSCDc1c8bd8b-7ff8-5940-e053-2995a90ae65613
857564trospium chloride 60 MG 24 HR Extended Release Oral CapsuleSYc1c8bd8b-7ff8-5940-e053-2995a90ae65613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70436-174-047043601740430 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-174-04) 2021-06-210000-00-00NoNoCurrent