Spiriva HandiHaler (tiotropium bromide) NDC 0597-0075

NDC codes

FDA NDC Directory

Product NDC (as listed)0597-0075Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00597-0075Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
0597-0075-41	00597007541	3 BLISTER PACK in 1 CARTON (0597-0075-41) / 10 CAPSULE in 1 BLISTER PACKMarketed from Oct 11, 2005
0597-0075-47	00597007547	9 BLISTER PACK in 1 CARTON (0597-0075-47) / 10 CAPSULE in 1 BLISTER PACKMarketed from Oct 11, 2005
0597-0075-75	00597007575	1 BLISTER PACK in 1 CARTON (0597-0075-75) / 5 CAPSULE in 1 BLISTER PACKMarketed from Oct 11, 2005

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Spiriva HandiHalerSuffix: HandiHaler
Generic name (nonproprietary): tiotropium bromide
Active ingredients: Tiotropium bromide monohydrate — 18 ug/1
Dosage form: Capsule
Route: Oral, Respiratory (Inhalation)
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021395
Marketing start: Oct 11, 2005
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Antagonists (Mechanism)
Identifiers: Product ID 0597-0075_94768574-0d3e-46f0-9f75-ab3c9f52857dSPL ID 94768574-0d3e-46f0-9f75-ab3c9f52857dSPL set ID 820839ef-e53d-47e8-a3b9-d911ff92e6a9RxCUI 485032, 580261UNII L64SXO195N
Pharmacologic class: Anticholinergic

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N400597007541 followed by a unit qualifier and the quantity

Package 00597-0075-41. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Label details couldn’t be retrieved right now. Open the label on DailyMed.