Spiriva - 54868-5109-1 - (tiotropium bromide monohydrate)

Alphabetical Index


Drug Information of Spiriva

Product NDC: 54868-5109
Proprietary Name: Spiriva
Non Proprietary Name: tiotropium bromide monohydrate
Active Ingredient(s): 18    ug/1 & nbsp;   tiotropium bromide monohydrate
Administration Route(s): ORAL; RESPIRATORY (INHALATION)
Dosage Form(s): CAPSULE
Coding System: National Drug Codes(NDC)

Labeler Information of Spiriva

Product NDC: 54868-5109
Labeler Name: Physicians Total Care, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA021395
Marketing Category: NDA
Start Marketing Date: 20040714

Package Information of Spiriva

Package NDC: 54868-5109-1
Package Description: 9 BLISTER PACK in 1 CARTON (54868-5109-1) > 10 CAPSULE in 1 BLISTER PACK

NDC Information of Spiriva

NDC Code 54868-5109-1
Proprietary Name Spiriva
Package Description 9 BLISTER PACK in 1 CARTON (54868-5109-1) > 10 CAPSULE in 1 BLISTER PACK
Product NDC 54868-5109
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name tiotropium bromide monohydrate
Dosage Form Name CAPSULE
Route Name ORAL; RESPIRATORY (INHALATION)
Start Marketing Date 20040714
Marketing Category Name NDA
Labeler Name Physicians Total Care, Inc.
Substance Name TIOTROPIUM BROMIDE MONOHYDRATE
Strength Number 18
Strength Unit ug/1
Pharmaceutical Classes Anticholinergic [EPC],Cholinergic Antagonists [MoA]

Complete Information of Spiriva


General Information