NDC 50090-4414

Spiriva

Tiotropium Bromide

Spiriva is a Oral; Respiratory (inhalation) Capsule in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Tiotropium Bromide Monohydrate.

• Product ID: 50090-4414_22fe8b5c-76a9-407d-9fec-9761e54555eb
• NDC: 50090-4414
• Product Type: Human Prescription Drug
• Proprietary Name: Spiriva
• Generic Name: Tiotropium Bromide
• Dosage Form: Capsule
• Route of Administration: ORAL; RESPIRATORY (INHALATION)
• Marketing Start Date: 2005-10-11
• Marketing Category: NDA / NDA
• Application Number: NDA021395
• Labeler Name: A-S Medication Solutions
• Substance Name: TIOTROPIUM BROMIDE MONOHYDRATE
• Active Ingredient Strength: 18 ug/1
• Pharm Classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 50090-4414-0

9 BLISTER PACK in 1 CARTON (50090-4414-0) > 10 CAPSULE in 1 BLISTER PACK

• Marketing Start Date: 2019-07-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-4414-0 [50090441400]

Spiriva CAPSULE

• Marketing Category: NDA
• Application Number: NDA021395
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-16

Drug Details

Active Ingredients

Ingredient	Strength
TIOTROPIUM BROMIDE MONOHYDRATE	18 ug/1

OpenFDA Data

• SPL SET ID: 25a4cb05-64a8-44b6-88c8-4292a5292e92
• Manufacturer:
  • A-S Medication Solutions
• UNII:
  • L64SXO195N
• RxNorm Concept Unique ID - RxCUI:
  • 485032
  • 580261

Pharmacological Class

• Anticholinergic [EPC]
• Cholinergic Antagonists [MoA]
• Anticholinergic [EPC]
• Cholinergic Antagonists [MoA]

NDC Crossover Matching brand name "Spiriva" or generic name "Tiotropium Bromide"

NDC	Brand Name	Generic Name
0597-0075	Spiriva	TIOTROPIUM BROMIDE
50090-4248	Spiriva	TIOTROPIUM BROMIDE
50090-4414	Spiriva	TIOTROPIUM BROMIDE