Trospium Chloride

Product NDC: 71335-2931
11-digit product format: 713352931
Labeler code: 71335
Product ID: 71335-2931_2b79aaf7-efd4-41c8-9b7c-cf40935fc010
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

openFDA Listing Details

Product ID: 71335-2931_2b79aaf7-efd4-41c8-9b7c-cf40935fc010
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Trospium Chloride
Brand name suffix: ER
Generic name: Trospium Chloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Marketing start: 2013-06-07
Marketing category: ANDA
Application number: ANDA201291
Pharmacologic classes: Cholinergic Muscarinic Antagonist [EPC]; Cholinergic Muscarinic Antagonists [MoA]
Listing expiration: 2026-12-31

Ingredient	Strength
TROSPIUM CHLORIDE	60 mg/1

UNII	Preferred term	Registry number	Matched term
1E6682427E	TROSPIUM CHLORIDE	10405-02-4	TROSPIUM CHLORIDE

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-2931-1	71335293101	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2931-1)	2025-10-21	No	No	Current

Title	Manufacturer	Effective date	Type	Version
Trospium Chloride ER	Bryant Ranch Prepack	2025-10-21	HUMAN PRESCRIPTION DRUG LABEL	100