Prescription drug · ANDA
Asenapine (asenapine maleate) NDC 69539-245
Asenapine maleate 2.5 mg/1 · Tablet · Sublingual · MSN LABORATORIES PRIVATE LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69539-245-34 | 69539024534 | 60 TABLET in 1 BOX (69539-245-34)Marketed from Aug 27, 2021 |
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 — 2.5 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 69539-245_0c0d566e-5315-4e29-a207-5f2eb75910f0SPL ID 0c0d566e-5315-4e29-a207-5f2eb75910f0SPL set ID 4c7a1b17-e73e-4417-a172-bfb03569d7ffRxCUI 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
N469539024534followed by a unit qualifier and the quantityPackage 69539-0245-34. 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.
Other NDCs under ANDA 205960
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 |
|---|---|---|---|---|
| Asenapineasenapine maleate | Asenapine maleate 5 mg/1 | TabletSublingual | MSN LABORATORIES PRIVATE LIMITED | 69539-058 |
| Asenapineasenapine maleate | Asenapine maleate 10 mg/1 | TabletSublingual | MSN LABORATORIES PRIVATE LIMITED | 69539-059 |
| Asenapineasenapine maleate | Asenapine maleate 10 mg/1 | TabletSublingual | MSN LABORATORIES PRIVATE LIMITED | 69539-060 |
| Asenapineasenapine maleate | Asenapine maleate 5 mg/1 | TabletSublingual | MSN LABORATORIES PRIVATE LIMITED | 69539-057 |
| Asenapineasenapine maleate | Asenapine maleate 10 mg/1 | TabletSublingual | Breckenridge Pharmaceutical, Inc. | 51991-361 |
| Asenapineasenapine maleate | Asenapine maleate 2.5 mg/1 | TabletSublingual | Breckenridge Pharmaceutical, Inc. | 51991-928 |
| Asenapineasenapine maleate | Asenapine maleate 10 mg/1 | TabletSublingual | Breckenridge Pharmaceutical, Inc. | 51991-360 |
| Asenapineasenapine maleate | Asenapine maleate 5 mg/1 | TabletSublingual | Breckenridge Pharmaceutical, Inc. | 51991-358 |
| Asenapineasenapine maleate | Asenapine maleate 5 mg/1 | TabletSublingual | Breckenridge Pharmaceutical, Inc. | 51991-359 |