Spiriva Respimat (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 1.25 mcg Carton

NDC 0597-0160-61

Spiriva® Respimat®
(tiotropium bromide inhalation spray)

1.25 mcg/actuation*

FOR ORAL INHALATION ONLY

Rx only

4 Grams
60 Metered Inhalations
(Two inhalations equal one dose)

Boehringer Ingelheim

PRINCIPAL DISPLAY PANEL -- 1.25 mcg Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 2.5 mcg Carton

NDC 0597-0100-61

Spiriva® Respimat®
(tiotropium bromide inhalation spray)

2.5 mcg/actuation*

FOR ORAL INHALATION ONLY

Rx only

4 Grams
60 Metered Inhalations
(Two inhalations equal one dose)

Boehringer Ingelheim

PRINCIPAL DISPLAY PANEL -- 2.5 mcg Carton
(click image for full-size original)
SPIRIVA RESPIMAT tiotropium bromide inhalation spray spray, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0597-0160
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIOTROPIUM BROMIDE ANHYDROUS (TIOTROPIUM) TIOTROPIUM BROMIDE ANHYDROUS 1.562 ug
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0597-0160-61 1 CARTRIDGE in 1 CARTON contains a CARTRIDGE
1 60 SPRAY, METERED in 1 CARTRIDGE This package is contained within the CARTON (0597-0160-61)
2 NDC:0597-0160-28 1 CARTRIDGE in 1 CARTON contains a CARTRIDGE
2 28 SPRAY, METERED in 1 CARTRIDGE This package is contained within the CARTON (0597-0160-28)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207070 09/15/2015
SPIRIVA RESPIMAT tiotropium bromide inhalation spray spray, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0597-0100
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIOTROPIUM BROMIDE ANHYDROUS (TIOTROPIUM) TIOTROPIUM BROMIDE ANHYDROUS 3.124 ug
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0597-0100-61 1 CARTRIDGE in 1 CARTON contains a CARTRIDGE
1 60 SPRAY, METERED in 1 CARTRIDGE This package is contained within the CARTON (0597-0100-61)
2 NDC:0597-0100-28 1 CARTRIDGE in 1 CARTON contains a CARTRIDGE
2 28 SPRAY, METERED in 1 CARTRIDGE This package is contained within the CARTON (0597-0100-28)
3 NDC:0597-0100-51 1 CARTRIDGE in 1 CARTON contains a CARTRIDGE
3 10 SPRAY, METERED in 1 CARTRIDGE This package is contained within the CARTON (0597-0100-51)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021936 09/30/2014
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 MANUFACTURE (0597-0100), MANUFACTURE (0597-0160), API MANUFACTURE (0597-0100), API MANUFACTURE (0597-0160), PACK (0597-0100), PACK (0597-0160), LABEL (0597-0100), LABEL (0597-0160)
Establishment
Name Address ID/FEI Operations
Boehringer Ingelheim España, S.A. 465561546 ANALYSIS (0597-0100), MANUFACTURE (0597-0100), PACK (0597-0100), LABEL (0597-0100)

Revised: 10/2023 Boehringer Ingelheim Pharmaceuticals, Inc.

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