Prescription drug · ANDA
Tiotropium Bromide NDC 68180-964
Tiotropium bromide monohydrate 18 ug/1 · Capsule · Oral, Respiratory (Inhalation) · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-964-12 | 68180096412 | 3 BLISTER PACK in 1 CARTON (68180-964-12) / 10 CAPSULE in 1 BLISTER PACKMarketed from Aug 16, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Tiotropium Bromide
- Generic name (nonproprietary)
- tiotropium bromide
- Active ingredients
- Tiotropium bromide monohydrate — 18 ug/1
- Dosage form
- Capsule
- Route
- Oral, Respiratory (Inhalation)
- Labeler
- Lupin Pharmaceuticals, Inc.NDC labeler code 68180
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211287
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 68180-964_87de16e4-1447-4bf6-90f6-705829efe684SPL ID 87de16e4-1447-4bf6-90f6-705829efe684SPL set ID 496b38ee-45b6-4bb2-a35e-9023c3b73719RxCUI 485032UNII L64SXO195NUPC 0368180964117
- 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
N468180096412followed by a unit qualifier and the quantityPackage 68180-0964-12. 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)
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. Tiotropium bromide inhalation powder is indicated to reduce exacerbations in COPD patients. Tiotropium bromide inhalation powder 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 68180-964
- What is NDC 68180-964?
- 68180-964 is the product NDC for Tiotropium Bromide, Tiotropium bromide monohydrate 18 ug/1 capsule, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tiotropium Bromide.
- What is the active ingredient?
- Tiotropium bromide monohydrate.
- Who is the labeler?
- Lupin Pharmaceuticals, Inc., NDC labeler code 68180. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tiotropium Bromide?
- 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.