Spiriva HandiHaler (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 30 Capsule Blister Pack Carton

NDC 0597-0075-41

SPIRIVA® HandiHaler®
(tiotropium bromide inhalation powder)

18 mcg/Capsule*

DO NOT SWALLOW SPIRIVA CAPSULES.
For Use With HandiHaler Device Only.

FOR ORAL INHALATION ONLY

Rx only
30 capsules
3 blister cards. Each card contains 10 capsules.

SPIRIVA capsules should only
be used with the HandiHaler
device and inhaled through
your mouth (oral inhalation).

Boehringer Ingelheim

PRINCIPAL DISPLAY PANEL -- 30 Capsule Blister Pack Carton
(click image for full-size original)
SPIRIVA HANDIHALER tiotropium bromide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0597-0075
Route of Administration ORAL, RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIOTROPIUM BROMIDE MONOHYDRATE (TIOTROPIUM) TIOTROPIUM 18 ug
Product Characteristics
Color GREEN Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code TI;01
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0597-0075-41 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (0597-0075-41)
2 NDC:0597-0075-75 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 5 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (0597-0075-75)
3 NDC:0597-0075-47 9 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (0597-0075-47)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021395 10/11/2005
Labeler — Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Registrant — Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Establishment
Name Address ID/FEI Operations
Boehringer Ingelheim Pharma GmbH and Co. KG 551147440 ANALYSIS (0597-0075), API MANUFACTURE (0597-0075), LABEL (0597-0075), MANUFACTURE (0597-0075), PACK (0597-0075)
Establishment
Name Address ID/FEI Operations
West-Ward Columbus Inc. 058839929 LABEL (0597-0075), PACK (0597-0075)

Revised: 01/2022 Boehringer Ingelheim Pharmaceuticals, Inc.

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