Prescription drug · NDA
Spiriva HandiHaler (Tiotropium bromide) NDC 50090-4248
Tiotropium bromide monohydrate 18 ug/1 · Capsule · Oral, Respiratory (Inhalation) · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-4248-0 | 50090424800 | 3 BLISTER PACK in 1 CARTON (50090-4248-0) / 10 CAPSULE in 1 BLISTER PACKMarketed from Apr 2, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021395
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 50090-4248_fa0b0258-3ff1-4481-a289-2599b2e3fd76SPL ID fa0b0258-3ff1-4481-a289-2599b2e3fd76SPL set ID ba462261-734a-4e9f-a5c0-5c676bc56a2eRxCUI 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
N450090424800followed by a unit qualifier and the quantityPackage 50090-4248-00. 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 HANDIHALER (tiotropium bromide inhalation powder) is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. SPIRIVA HANDIHALER is indicated to reduce exacerbations in COPD patients. SPIRIVA HANDIHALER 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 )
Excerpt only. Read the full label for complete information.
About NDC 50090-4248
- What is NDC 50090-4248?
- 50090-4248 is the product NDC for Spiriva HandiHaler (tiotropium bromide), Tiotropium bromide monohydrate 18 ug/1 capsule, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Spiriva HandiHaler (Tiotropium bromide).
- What is the active ingredient?
- Tiotropium bromide monohydrate.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. 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 HandiHaler?
- 2 other product NDCs are listed under this name. See all Spiriva HandiHaler NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Spiriva HandiHaler 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 HandiHalertiotropium bromide | Tiotropium bromide monohydrate 18 ug/1 | CapsuleOral, Respiratory (Inhalation) | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0075 | 00597-0075-4100597-0075-4700597-0075-75 |
| Spiriva HandiHalertiotropium bromide | Tiotropium bromide monohydrate 18 ug/1 | CapsuleOral, Respiratory (Inhalation) | A-S Medication Solutions | 50090-7645 | 50090-7645-00 |
Other NDCs under NDA 021395
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Spiriva HandiHalertiotropium bromide | Tiotropium bromide monohydrate 18 ug/1 | CapsuleOral, Respiratory (Inhalation) | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0075 |
| Spiriva HandiHalertiotropium bromide | Tiotropium bromide monohydrate 18 ug/1 | CapsuleOral, Respiratory (Inhalation) | A-S Medication Solutions | 50090-7645 |