Prescription drug · NDA
Secuado (Asenapine) NDC 68968-0173
Asenapine 5.7 mg/d · Film, Extended release · Transdermal · Noven Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68968-0173-3 | 6896801730368968017303 | 30 POUCH in 1 CARTON (68968-0173-3) / 1 d in 1 POUCHMarketed from Feb 12, 2020 | |
| 68968-0173-7 | 6896801730768968017307 | 7 POUCH in 1 CARTON (68968-0173-7) / 1 d in 1 POUCHMarketed from Feb 12, 2020 |
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)
- Secuado
- Generic name (nonproprietary)
- asenapine
- Active ingredients
- Asenapine — 5.7 mg/d
- Dosage form
- Film, Extended release
- Route
- Transdermal
- Labeler
- Noven Therapeutics, LLCNDC labeler code 68968
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212268
- Marketing start
- Listing expires
- Identifiers
- Product ID 68968-0173_ae8030f1-3ed5-40cf-a726-de4c14ee8c1cSPL ID ae8030f1-3ed5-40cf-a726-de4c14ee8c1cSPL set ID 685eaf44-5944-4f38-afba-0a4fc0b3462bRxCUI 2261741, 2261750, 2261758, 2265729, 2265732, 2265735UNII JKZ19V908O
- Pharmacologic class
- Atypical Antipsychotic
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 HCPCS code in Med-Code's directory. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468968017303followed by a unit qualifier and the quantityPackage 68968-0173-03. 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)
SECUADO is indicated for the treatment of adults with schizophrenia [ see Clinical Studies (14) ]. SECUADO is an atypical antipsychotic indicated for the treatment of adults with schizophrenia. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 68968-0173
- What is NDC 68968-0173?
- 68968-0173 is the product NDC for Secuado (asenapine), Asenapine 5.7 mg/d film, extended release, listed with the FDA by Noven Therapeutics, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Secuado (Asenapine).
- What is the active ingredient?
- Asenapine.
- Who is the labeler?
- Noven Therapeutics, LLC, NDC labeler code 68968. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Secuado?
- 2 other product NDCs are listed under this name. See all Secuado NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Secuado products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Secuadoasenapine | Asenapine 3.8 mg/d | Film, Extended releaseTransdermal | Noven Therapeutics, LLC | 68968-0172 | 68968-0172-0368968-0172-07 |
| Secuadoasenapine | Asenapine 7.6 mg/d | Film, Extended releaseTransdermal | Noven Therapeutics, LLC | 68968-0174 | 68968-0174-0368968-0174-07 |
Other NDCs under NDA 212268
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 |
|---|---|---|---|---|
| Secuadoasenapine | Asenapine 3.8 mg/d | Film, Extended releaseTransdermal | Noven Therapeutics, LLC | 68968-0172 |
| Secuadoasenapine | Asenapine 7.6 mg/d | Film, Extended releaseTransdermal | Noven Therapeutics, LLC | 68968-0174 |