FDA.reportPublic FDA data

TROSPIUM CHLORIDE

Product NDC
71205-917
11-digit product format
712050917
Labeler code
71205
Product ID
71205-917_a429ee21-0214-4c69-a264-352ecd758d87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TROSPIUM CHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
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
71205-917-00TROSPIUM CHLORIDE100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1002
71205-917-30TROSPIUM CHLORIDE30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302
71205-917-55TROSPIUM CHLORIDE500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5002
71205-917-60TROSPIUM CHLORIDE60 in 1 BOTTLECAPSULE, EXTENDED RELEASE602
71205-917-72TROSPIUM CHLORIDE120 in 1 BOTTLECAPSULE, EXTENDED RELEASE1202
71205-917-90TROSPIUM CHLORIDE90 in 1 BOTTLECAPSULE, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-917-00EA - Each71205-917e24c6eab-e99b-41a1-acad-d9e9517f0d9912021-08-05
71205-917-55EA - Each71205-917894ef374-38e3-4831-ba3c-97e393bda89812021-08-05
71205-917-60EA - Each71205-91705bf79ea-36b8-4803-b490-d6114310190212021-08-05
71205-917-72EA - Each71205-9171713b4d2-f071-4b87-92c4-e7d3119a871d12021-08-05
71205-917-90EA - Each71205-917a4fcb11b-a8a0-4b7d-800f-5a4e7f50d7c212021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-917TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 6 package rows20220409_5d0390ff-185d-41a7-9495-bb8006a05def.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
71205-917-0071205091700100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-917-00) 2021-07-080000-00-00NoNoCurrent
71205-917-307120509173030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-917-30) 2021-07-080000-00-00NoNoCurrent
71205-917-5571205091755500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-917-55) 2021-07-080000-00-00NoNoCurrent
71205-917-607120509176060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-917-60) 2021-07-080000-00-00NoNoCurrent
71205-917-7271205091772120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-917-72) 2021-07-080000-00-00NoNoCurrent
71205-917-907120509179090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-917-90) 2021-07-080000-00-00NoNoCurrent