Prescription drug · ANDA
Asenapine NDC 46708-544
Asenapine 2.5 mg/1 · Tablet · Sublingual · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-544-31 | 4670805443146708054431 | 100 BLISTER PACK in 1 CARTON (46708-544-31) / 10 TABLET in 1 BLISTER PACKMarketed from Jul 20, 2021 | |
| 46708-544-60 | 4670805446046708054460 | 60 BLISTER PACK in 1 CARTON (46708-544-60) / 10 TABLET in 1 BLISTER PACK (46708-544-10)Marketed from Jul 20, 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
- Active ingredients
- Asenapine — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Sublingual
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206098
- Marketing start
- Listing expires
- Identifiers
- Product ID 46708-544_b8b5c58b-40db-4b6f-b53d-f11a842bcf28SPL ID b8b5c58b-40db-4b6f-b53d-f11a842bcf28SPL set ID cf587c48-9cd2-4dc5-b0e9-21783c5633a6RxCUI 859975, 859981, 1606337UNII 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. Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N446708054431followed by a unit qualifier and the quantityPackage 46708-0544-31. 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 is indicated for: • Bipolar I disorder [see Clinical Studies (14.2)] • Acute monotherapy of manic or mixed episodes, in pediatric patients 10 to 17 years of age • Adjunctive treatment to lithium or valproate in adults Asenapine is an atypical antipsychotic indicated for (1): Bipolar I disorder o Acute monotherapy treatment of manic or mixed episodes, in pediatric patients 10 to 17 years of age o Adjunctive treatment to lithium or valproate in adults
Excerpt only. Read the full label for complete information.
About NDC 46708-544
- What is NDC 46708-544?
- 46708-544 is the product NDC for Asenapine, Asenapine 2.5 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Asenapine.
- What is the active ingredient?
- Asenapine.
- Who is the labeler?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Asenapine?
- 17 other product NDCs are listed under this name. See all Asenapine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Asenapine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Asenapineasenapine maleate | Asenapine maleate 5 mg/1 | TabletSublingual | MSN LABORATORIES PRIVATE LIMITED | 69539-057 | 69539-0057-34 |
| Asenapineasenapine maleate | Asenapine maleate 5 mg/1 | TabletSublingual | MSN LABORATORIES PRIVATE LIMITED | 69539-058 | 69539-0058-34 |
| Asenapineasenapine maleate | Asenapine maleate 10 mg/1 | TabletSublingual | MSN LABORATORIES PRIVATE LIMITED | 69539-059 | 69539-0059-34 |
| Asenapineasenapine maleate | Asenapine maleate 10 mg/1 | TabletSublingual | MSN LABORATORIES PRIVATE LIMITED | 69539-060 | 69539-0060-34 |
| Asenapineasenapine maleate | Asenapine maleate 2.5 mg/1 | TabletSublingual | MSN LABORATORIES PRIVATE LIMITED | 69539-245 | 69539-0245-34 |
| Asenapine | Asenapine 2.5 mg/1 | TabletSublingual | Alembic Pharmaceuticals Inc. | 62332-544 | 62332-0544-3162332-0544-60 |
| Asenapineasenapine maleate | Asenapine maleate 5 mg/1 | TabletSublingual | Breckenridge Pharmaceutical, Inc. | 51991-358 | 51991-0358-1151991-0358-60 |
| Asenapineasenapine maleate | Asenapine maleate 5 mg/1 | TabletSublingual | Breckenridge Pharmaceutical, Inc. | 51991-359 | 51991-0359-1151991-0359-60 |
| Asenapine | Asenapine 5 mg/1 | TabletSublingual | Sigmapharm Laboratories, LLC | 42794-016 | 42794-0016-0842794-0016-1042794-0016-22 |
| Asenapine | Asenapine 10 mg/1 | TabletSublingual | Sigmapharm Laboratories, LLC | 42794-017 | 42794-0017-0842794-0017-1042794-0017-22 |
Other NDCs under ANDA 206098
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 |
|---|---|---|---|---|
| Asenapine | Asenapine 5 mg/1 | TabletSublingual | Alembic Pharmaceuticals Limited | 46708-198 |
| Asenapine | Asenapine 10 mg/1 | TabletSublingual | Alembic Pharmaceuticals Limited | 46708-199 |
| Asenapine | Asenapine 5 mg/1 | TabletSublingual | Alembic Pharmaceuticals Inc. | 62332-198 |
| Asenapine | Asenapine 10 mg/1 | TabletSublingual | Alembic Pharmaceuticals Inc. | 62332-199 |
| Asenapine | Asenapine 2.5 mg/1 | TabletSublingual | Alembic Pharmaceuticals Inc. | 62332-544 |