Prescription drug · ANDA
Asenapine (asenapine maleate) NDC 51991-360
Asenapine maleate 10 mg/1 · Tablet · Sublingual · Breckenridge Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51991-360-11 | 51991036011 | 10 BLISTER PACK in 1 BOX (51991-360-11) / 10 TABLET in 1 BLISTER PACK (51991-360-99)Marketed from Dec 10, 2020 | |
| 51991-360-60 | 51991036060 | 6 BLISTER PACK in 1 BOX (51991-360-60) / 10 TABLET in 1 BLISTER PACKMarketed from Dec 10, 2020 |
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)
- Asenapine
- Generic name (nonproprietary)
- asenapine maleate
- Active ingredients
- Asenapine maleate — 10 mg/1
- Dosage form
- Tablet
- Route
- Sublingual
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205960
- Marketing start
- Listing expires
- Identifiers
- Product ID 51991-360_b48a6c73-5ff9-46da-ae10-6fc0ced6afc7SPL ID b48a6c73-5ff9-46da-ae10-6fc0ced6afc7SPL set ID f5cd9abb-40e3-4cb5-a1b2-40cdba8a1c7eRxCUI 859975, 859981, 1606337UNII CU9463U2E2
- 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. Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N451991036011followed by a unit qualifier and the quantityPackage 51991-0360-11. 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)
Asenapine sublingual tablets are indicated for: Schizophrenia in adults [see Clinical Studies (14.1) ] Bipolar I disorder [see Clinical Studies (14.2) ] Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age Adjunctive treatment to lithium or valproate in adults Maintenance monotherapy treatment in adults Asenapine sublingual tablets are an atypical antipsychotic indicated for ( 1 ): Schizophrenia in adults Bipolar I disorder Acute monotherapy treatment of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age Adjunctive treatment to lithium or valproate in adults Maintenance monotherapy treatment in adults…
Excerpt only. Read the full label for complete information.