NDC 50090-7645-00 - Spiriva HandiHaler

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 50090-7645
Requested NDC: 50090-7645-00
Package NDCs from labels: 50090-7645-0, 50090-7645-00
Manufacturer: A-S Medication Solutions
Effective date: 2025-09-02
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Spiriva HandiHaler - A-S Medication Solutions	A-S Medication Solutions	2025-09-02	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-7645-0	Spiriva HandiHaler	10 in 1 BLISTER PACK	CAPSULE	10		1
50090-7645-0	Spiriva HandiHaler	3 in 1 CARTON	CAPSULE	3		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7645-0	EA - Each	50090-7645	bd39ec08-5574-4178-993c-237fd9e1465b	1	2025-10-14

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tiotropium Bromide	TIOTROPIUM BROMIDE	Lupin Pharmaceuticals, Inc.	496b38ee-45b6-4bb2-a35e-9023c3b73719	2025-11-11	Warnings, Adverse reactions	Exact identifier rxcui: 485032 unii: L64SXO195N
Spiriva HandiHaler	TIOTROPIUM BROMIDE	Boehringer Ingelheim Pharmaceuticals, Inc.	820839ef-e53d-47e8-a3b9-d911ff92e6a9	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: NDA021395 ndc (product): 0597-0075 rxcui: 580261 rxcui: 485032 spl id: 94768574-0d3e-46f0-9f75-ab3c9f52857d spl set id: 820839ef-e53d-47e8-a3b9-d911ff92e6a9 unii: L64SXO195N
Spiriva HandiHaler	TIOTROPIUM BROMIDE	A-S Medication Solutions	c6343458-617b-41ed-8e96-763e91dc8e90	2025-09-02	Warnings, Adverse reactions	Exact identifier application number: NDA021395 ndc (package): 50090-7645-0 ndc (product): 50090-7645 ndc11 (package): 50090764500 rxcui: 580261 rxcui: 485032 spl id: 70e86c70-cb36-45d0-853c-9840b3dad9b9 spl set id: c6343458-617b-41ed-8e96-763e91dc8e90 unii: L64SXO195N
Stiolto Respimat	TIOTROPIUM BROMIDE AND OLODATEROL	Boehringer Ingelheim Pharmaceuticals, Inc.	01e15aee-40e0-23f3-537f-c96dd63e2cb1	2025-06-30	Warnings, Adverse reactions	Exact identifier unii: L64SXO195N
Spiriva HandiHaler	TIOTROPIUM BROMIDE	A-S Medication Solutions	ba462261-734a-4e9f-a5c0-5c676bc56a2e	2023-02-06	Warnings, Adverse reactions	Exact identifier application number: NDA021395 rxcui: 580261 rxcui: 485032 unii: L64SXO195N

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.