Prescription drug · NDA
Adasuve (Loxapine) NDC 51097-001
Loxapine 10 mg/1 · Aerosol, Powder · Respiratory (Inhalation) · Alexza Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51097-001-02 | 51097000102 | 5 INHALER in 1 CARTON (51097-001-02) / 1 AEROSOL, POWDER in 1 INHALER (51097-001-01)Marketed from Jul 6, 2026 |
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)
- Adasuve
- Generic name (nonproprietary)
- loxapine
- Active ingredients
- Loxapine — 10 mg/1
- Dosage form
- Aerosol, Powder
- Route
- Respiratory (Inhalation)
- Labeler
- Alexza Pharmaceuticals, Inc.NDC labeler code 51097
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022549
- Marketing start
- Listing expires
- Identifiers
- Product ID 51097-001_55f64763-e6eb-4ca3-e063-6394a90a2541SPL ID 55f64763-e6eb-4ca3-e063-6394a90a2541SPL set ID 50e11732-7387-452d-b3e6-db3a431d5c4aRxCUI 1367518, 1367521UNII LER583670J
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
N451097000102followed by a unit qualifier and the quantityPackage 51097-0001-02. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
ADASUVE is indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults [see Clinical Studies (14) ] . ADASUVE is an atypical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults ( 1 ). Limitations of Use: ADASUVE must be administered only in a certified healthcare setting ( 1 ). Limitations of Use: As part of the ADASUVE REMS Program to mitigate the risk of bronchospasm, ADASUVE must be administered only in a certified healthcare setting [see Warnings and Precautions (5.2) ] .
Excerpt only. Read the full label for complete information.
About NDC 51097-001
- What is NDC 51097-001?
- 51097-001 is the product NDC for Adasuve (loxapine), Loxapine 10 mg/1 aerosol, powder, listed with the FDA by Alexza Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Adasuve (Loxapine).
- What is the active ingredient?
- Loxapine.
- Who is the labeler?
- Alexza Pharmaceuticals, Inc., NDC labeler code 51097. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Adasuve?
- 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.