What is NDC 0597-0155?

0597-0155 is the product NDC for Stiolto Respimat, Tiotropium bromide monohydrate 3.124 ug/1; Olodaterol hydrochloride 2.736 ug/1 spray, metered, listed with the FDA by Boehringer Ingelheim Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Stiolto Respimat (Tiotropium bromide and olodaterol).

What is the active ingredient?

Tiotropium bromide monohydrate, Olodaterol hydrochloride.

Boehringer Ingelheim Pharmaceuticals, Inc., NDC labeler code 0597. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Stiolto Respimat?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Stiolto Respimat NDC 0597-0155 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0597-0155Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00597-0155Add 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
0597-0155-28	00597015528	1 CARTRIDGE in 1 CARTON (0597-0155-28) / 28 SPRAY, METERED in 1 CARTRIDGEMarketed from May 21, 2015
0597-0155-61	00597015561	1 CARTRIDGE in 1 CARTON (0597-0155-61) / 60 SPRAY, METERED in 1 CARTRIDGEMarketed from May 21, 2015
0597-0155-70	00597015570	1 CARTRIDGE in 1 CARTON (0597-0155-70) / 10 SPRAY, METERED in 1 CARTRIDGEMarketed from Mar 22, 2019

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): Stiolto Respimat
Generic name (nonproprietary): tiotropium bromide and olodaterol
Active ingredients: Tiotropium bromide monohydrate — 3.124 ug/1Olodaterol hydrochloride — 2.736 ug/1
Dosage form: Spray, Metered
Route: Respiratory (Inhalation)
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.NDC labeler code 0597
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 206756
Marketing start: May 21, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)Cholinergic Antagonists (Mechanism)
Identifiers: Product ID 0597-0155_79996212-633b-464e-9967-834039fb13a4SPL ID 79996212-633b-464e-9967-834039fb13a4SPL set ID 01e15aee-40e0-23f3-537f-c96dd63e2cb1RxCUI 1651266, 1651271, 1651274, 1651275, 2166927, 2166928UNII L64SXO195N, 65R445W3V9
Pharmacologic class: Anticholinergic; beta2-Adrenergic Agonist

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

N400597015528 followed by a unit qualifier and the quantity

Package 00597-0155-28. 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

Current FDA label (SPL), effective Jun 30, 2025.

Indications (excerpt from the label)

STIOLTO RESPIMAT is a combination of tiotropium bromide, an anticholinergic and olodaterol, a long-acting beta 2 -adrenergic agonist (LABA) indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ( 1.1 ) Important limitations: STIOLTO RESPIMAT is NOT indicated to treat acute deterioration of COPD. ( 1.1 ) STIOLTO RESPIMAT is NOT indicated to treat asthma. ( 1.1 ) 1.1 Maintenance Treatment of COPD STIOLTO RESPIMAT is a combination of tiotropium bromide and olodaterol indicated for long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emp…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0597-0155

What is NDC 0597-0155?: 0597-0155 is the product NDC for Stiolto Respimat, Tiotropium bromide monohydrate 3.124 ug/1; Olodaterol hydrochloride 2.736 ug/1 spray, metered, listed with the FDA by Boehringer Ingelheim Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Stiolto Respimat (Tiotropium bromide and olodaterol).
What is the active ingredient?: Tiotropium bromide monohydrate, Olodaterol hydrochloride.
Who is the labeler?: Boehringer Ingelheim Pharmaceuticals, Inc., NDC labeler code 0597. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Stiolto Respimat?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Stiolto Respimat (Tiotropium bromide and olodaterol) NDC 0597-0155