NDC 50090-4248

Spiriva HandiHaler

Tiotropium Bromide

Spiriva HandiHaler 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: 50090-4248_ea5c1e40-4795-4e99-821d-d53727b16b7f
• NDC: 50090-4248
• Product Type: Human Prescription Drug
• Proprietary Name: Spiriva HandiHaler
• 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 50090-4248-0

3 BLISTER PACK in 1 CARTON (50090-4248-0) > 10 CAPSULE in 1 BLISTER PACK

• Marketing Start Date: 2019-04-02
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

NDC Crossover Matching brand name "Spiriva HandiHaler" 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