TROSPIUM CHLORIDE

Product NDC
70010-027
11-digit product format
700100027
Labeler code
70010
Product ID
70010-027_0194b277-edb7-e7f8-e063-6394a90a6c25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TROSPIUM CHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA213185
Marketing category
ANDA
Marketing start
2020-08-19
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
70010-027-03TROSPIUM CHLORIDE30 in 1 BOTTLECAPSULE, EXTENDED RELEASE307
70010-027-05TROSPIUM CHLORIDE500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-027TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 2 package rows20230730_5c088397-f407-4606-95a0-d9fe619888c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857564trospium chloride 60 MG 24HR Extended Release Oral CapsulePSN5c088397-f407-4606-95a0-d9fe619888c37
85756424 HR trospium chloride 60 MG Extended Release Oral CapsuleSCD5c088397-f407-4606-95a0-d9fe619888c37
857564trospium chloride 60 MG 24 HR Extended Release Oral CapsuleSY5c088397-f407-4606-95a0-d9fe619888c37
857564trospium chloride 60 MG 24HR Extended Release Oral CapsulePSN5d0390ff-185d-41a7-9495-bb8006a05def2
85756424 HR trospium chloride 60 MG Extended Release Oral CapsuleSCD5d0390ff-185d-41a7-9495-bb8006a05def2
857564trospium chloride 60 MG 24 HR Extended Release Oral CapsuleSY5d0390ff-185d-41a7-9495-bb8006a05def2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70010-027-037001000270330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-027-03) 2020-08-190000-00-00NoNoCurrent
70010-027-0570010002705500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-027-05) 2020-08-190000-00-00NoNoCurrent