Prescription drug · NDA
Saphris (Asenapine maleate) NDC 0456-2402
Asenapine maleate 2.5 mg/1 · Tablet · Sublingual · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0456-2402-10 | 0045624021000456240210 | 1 CASE in 1 CARTON (0456-2402-10) / 1 BLISTER PACK in 1 CASE / 10 TABLET in 1 BLISTER PACKMarketed from Dec 30, 2014 · Sample package | |
| 0456-2402-60 | 0045624026000456240260 | 6 CASE in 1 CARTON (0456-2402-60) / 1 BLISTER PACK in 1 CASE (0456-2402-06) / 10 TABLET in 1 BLISTER PACKMarketed from Dec 30, 2014 | |
| 0456-2402-63 | 0045624026300456240263 | 10 BLISTER PACK in 1 CARTON (0456-2402-63) / 10 TABLET in 1 BLISTER PACK (0456-2402-11)Marketed from Dec 30, 2014 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Saphris
- Generic name (nonproprietary)
- asenapine maleate
- Active ingredients
- Asenapine maleate — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Sublingual
- Labeler
- Allergan, Inc.NDC labeler code 0456
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022117
- Marketing start
- Listing expires
- Identifiers
- Product ID 0456-2402_9827c4dd-ffac-4022-a021-d1b15a364ecdSPL ID 9827c4dd-ffac-4022-a021-d1b15a364ecdSPL set ID 5429f134-839f-4ffc-9944-55f51238def8RxCUI 859975, 859979, 859981, 859983, 1606337, 1606490UNII 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
N400456240210followed by a unit qualifier and the quantityPackage 00456-2402-10. 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)
1 INDICATIONS AN D USAGE SAPHRIS is 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 SAPHRIS is 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.
About NDC 0456-2402
- What is NDC 0456-2402?
- 0456-2402 is the product NDC for Saphris (asenapine maleate), Asenapine maleate 2.5 mg/1 tablet, listed with the FDA by Allergan, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Saphris (Asenapine Maleate).
- What is the active ingredient?
- Asenapine maleate.
- Who is the labeler?
- Allergan, Inc., NDC labeler code 0456. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Saphris?
- 2 other product NDCs are listed under this name. See all Saphris NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Saphris products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Saphrisasenapine maleate | Asenapine maleate 5 mg/1 | TabletSublingual | Allergan, Inc. | 0456-2405 | 00456-2405-1000456-2405-60 |
| Saphrisasenapine maleate | Asenapine maleate 10 mg/1 | TabletSublingual | Allergan, Inc. | 0456-2410 | 00456-2410-1000456-2410-60 |
Other NDCs under NDA 022117
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 |
|---|---|---|---|---|
| Saphrisasenapine maleate | Asenapine maleate 5 mg/1 | TabletSublingual | Allergan, Inc. | 0456-2405 |
| Saphrisasenapine maleate | Asenapine maleate 10 mg/1 | TabletSublingual | Allergan, Inc. | 0456-2410 |