NDC 0597-0160

Spiriva Respimat

Tiotropium Bromide Inhalation Spray

Spiriva Respimat is a Respiratory (inhalation) Spray, Metered in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Tiotropium Bromide Anhydrous.

• Product ID: 0597-0160_2ef119c5-33ec-4d21-a3b4-01d07875253e
• NDC: 0597-0160
• Product Type: Human Prescription Drug
• Proprietary Name: Spiriva Respimat
• Generic Name: Tiotropium Bromide Inhalation Spray
• Dosage Form: Spray, Metered
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2015-09-15
• Marketing Category: NDA / NDA
• Application Number: NDA207070
• Labeler Name: Boehringer Ingelheim Pharmaceuticals, Inc.
• Substance Name: TIOTROPIUM BROMIDE ANHYDROUS
• Active Ingredient Strength: 2 ug/1
• Pharm Classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0597-0160-28

1 CARTRIDGE in 1 CARTON (0597-0160-28) > 28 SPRAY, METERED in 1 CARTRIDGE

• Marketing Start Date: 2015-09-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0597-0160-31 [00597016031]

Spiriva Respimat SPRAY, METERED

• Marketing Category: NDA
• Application Number: NDA207070
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-09-15
• Marketing End Date: 2017-03-01

NDC 0597-0160-61 [00597016061]

Spiriva Respimat SPRAY, METERED

• Marketing Category: NDA
• Application Number: NDA207070
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2015-09-15

NDC 0597-0160-28 [00597016028]

Spiriva Respimat SPRAY, METERED

• Marketing Category: NDA
• Application Number: NDA207070
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-09-15

Drug Details

Active Ingredients

Ingredient	Strength
TIOTROPIUM BROMIDE	1.562 ug/1

OpenFDA Data

• SPL SET ID: 7b656b14-fcaa-2741-f6f0-e0be48971c02
• Manufacturer:
  • Boehringer Ingelheim Pharmaceuticals, Inc.
• UNII:
  • XX112XZP0J
• RxNorm Concept Unique ID - RxCUI:
  • 1667882
  • 1552008
  • 1552009
  • 1667886
  • 1667885
  • 1552002
  • 1552004
  • 1667880

Pharmacological Class

• Anticholinergic [EPC]
• Cholinergic Antagonists [MoA]

NDC Crossover Matching brand name "Spiriva Respimat" or generic name "Tiotropium Bromide Inhalation Spray"

NDC	Brand Name	Generic Name
0597-0100	Spiriva Respimat	tiotropium bromide inhalation spray
0597-0160	Spiriva Respimat	tiotropium bromide inhalation spray