Prescription drug · NDA
Spiriva Respimat (Tiotropium bromide inhalation spray) NDC 0597-0100
Tiotropium bromide anhydrous 3.124 ug/1 · Spray, Metered · Respiratory (Inhalation) · Boehringer Ingelheim Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0597-0100-28 | 00597010028 | 1 CARTRIDGE in 1 CARTON (0597-0100-28) / 28 SPRAY, METERED in 1 CARTRIDGEMarketed from Sep 30, 2014 | |
| 0597-0100-51 | 00597010051 | 1 CARTRIDGE in 1 CARTON (0597-0100-51) / 10 SPRAY, METERED in 1 CARTRIDGEMarketed from Mar 15, 2019 | |
| 0597-0100-61 | 00597010061 | 1 CARTRIDGE in 1 CARTON (0597-0100-61) / 60 SPRAY, METERED in 1 CARTRIDGEMarketed from Sep 30, 2014 |
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 Respimat
- Generic name (nonproprietary)
- tiotropium bromide inhalation spray
- Active ingredients
- Tiotropium bromide anhydrous — 3.124 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 021936
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 0597-0100_e44a3eea-f679-45fc-994a-0e960975b36bSPL ID e44a3eea-f679-45fc-994a-0e960975b36bSPL set ID 7b656b14-fcaa-2741-f6f0-e0be48971c02RxCUI 1552002, 1552004, 1552008, 1552009, 1667880, 1667882, 1667885, 1667886, 2166203, 2166204UNII XX112XZP0J
- 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
N400597010028followed by a unit qualifier and the quantityPackage 00597-0100-28. 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 .
Indications (excerpt from the label)
SPIRIVA RESPIMAT is an anticholinergic indicated for: The long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), and for reducing COPD exacerbations ( 1.1 ) The long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older ( 1.2 ) Limitation of Use: Not indicated for relief of acute bronchospasm ( 1.1 , 1.2 , 5.1 ) 1.1 Maintenance Treatment of Chronic Obstructive Pulmonary Disease SPIRIVA RESPIMAT (tiotropium bromide) is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emp…
Excerpt only. Read the full label for complete information.
About NDC 0597-0100
- What is NDC 0597-0100?
- 0597-0100 is the product NDC for Spiriva Respimat (tiotropium bromide inhalation spray), Tiotropium bromide anhydrous 3.124 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?
- Spiriva Respimat (Tiotropium bromide inhalation spray).
- What is the active ingredient?
- Tiotropium bromide anhydrous.
- 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 Spiriva Respimat?
- 1 other product NDC are listed under this name. See all Spiriva Respimat NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Spiriva Respimat products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Spiriva Respimattiotropium bromide inhalation spray | Tiotropium bromide anhydrous 1.562 ug/1 | Spray, MeteredRespiratory (Inhalation) | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0160 | 00597-0160-2800597-0160-61 |