stiolto respimat (0597-0155)

Drug Facts

Product Profile

Brand Name stiolto respimat

Generic Name tiotropium bromide and olodaterol

Labeler boehringer ingelheim pharmaceuticals, inc.

Dosage Form SPRAY, METERED

Routes

RESPIRATORY (INHALATION)

Active Ingredients

olodaterol hydrochloride 2.736 ug/1, tiotropium bromide monohydrate 3.124 ug/1

Manufacturer

Boehringer Ingelheim Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0597-0155

Product ID 0597-0155_79996212-633b-464e-9967-834039fb13a4

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA

Application Number NDA206756

Listing Expiration 2026-12-31

Marketing Start 2015-05-21

Pharmacologic Class

Classes

adrenergic beta2-agonists [moa] anticholinergic [epc] cholinergic antagonists [moa] beta2-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05970155

Hyphenated Format 0597-0155

Supplemental Identifiers

RxCUI

1651266 1651271 1651274 1651275 2166927 2166928

UNII

65R445W3V9 L64SXO195N

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name stiolto respimat (source: ndc)

Generic Name tiotropium bromide and olodaterol (source: ndc)

Application Number NDA206756 (source: ndc)

Routes

RESPIRATORY (INHALATION)

source: ndc

Resolved Composition

Strengths

2.736 ug/1
3.124 ug/1

source: ndc

Packaging

1 CARTRIDGE in 1 CARTON (0597-0155-28) / 28 SPRAY, METERED in 1 CARTRIDGE
1 CARTRIDGE in 1 CARTON (0597-0155-61) / 60 SPRAY, METERED in 1 CARTRIDGE
1 CARTRIDGE in 1 CARTON (0597-0155-70) / 10 SPRAY, METERED in 1 CARTRIDGE

source: ndc

Packages (3)

0597-0155-28 1 CARTRIDGE in 1 CARTON (0597-0155-28) / 28 SPRAY, METERED in 1 CARTRIDGE 0597-0155-61 1 CARTRIDGE in 1 CARTON (0597-0155-61) / 60 SPRAY, METERED in 1 CARTRIDGE 0597-0155-70 1 CARTRIDGE in 1 CARTON (0597-0155-70) / 10 SPRAY, METERED in 1 CARTRIDGE

Ingredients (2)

olodaterol hydrochloride (2.736 ug/1) tiotropium bromide monohydrate (3.124 ug/1)

Linked Drug Pages (1)

Stiolto Respimat ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "79996212-633b-464e-9967-834039fb13a4", "openfda": {"unii": ["65R445W3V9", "L64SXO195N"], "rxcui": ["1651266", "1651271", "1651274", "1651275", "2166927", "2166928"], "spl_set_id": ["01e15aee-40e0-23f3-537f-c96dd63e2cb1"], "manufacturer_name": ["Boehringer Ingelheim Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CARTRIDGE in 1 CARTON (0597-0155-28)  / 28 SPRAY, METERED in 1 CARTRIDGE", "package_ndc": "0597-0155-28", "marketing_start_date": "20150521"}, {"sample": false, "description": "1 CARTRIDGE in 1 CARTON (0597-0155-61)  / 60 SPRAY, METERED in 1 CARTRIDGE", "package_ndc": "0597-0155-61", "marketing_start_date": "20150521"}, {"sample": false, "description": "1 CARTRIDGE in 1 CARTON (0597-0155-70)  / 10 SPRAY, METERED in 1 CARTRIDGE", "package_ndc": "0597-0155-70", "marketing_start_date": "20190322"}], "brand_name": "Stiolto Respimat", "product_id": "0597-0155_79996212-633b-464e-9967-834039fb13a4", "dosage_form": "SPRAY, METERED", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0597-0155", "generic_name": "tiotropium bromide and olodaterol", "labeler_name": "Boehringer Ingelheim Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Stiolto Respimat", "active_ingredients": [{"name": "OLODATEROL HYDROCHLORIDE", "strength": "2.736 ug/1"}, {"name": "TIOTROPIUM BROMIDE MONOHYDRATE", "strength": "3.124 ug/1"}], "application_number": "NDA206756", "marketing_category": "NDA", "marketing_start_date": "20150521", "listing_expiration_date": "20261231"}