Prescription drug · ANDA
Asenapine (Asenapine maleate) NDC 51991-361
Asenapine maleate 10 mg/1 · Tablet · Sublingual · Breckenridge Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51991-361-11 | 5199103611151991036111 | 10 BLISTER PACK in 1 BOX (51991-361-11) / 10 TABLET in 1 BLISTER PACK (51991-361-99)Marketed from Dec 10, 2020 | |
| 51991-361-60 | 5199103616051991036160 | 6 BLISTER PACK in 1 BOX (51991-361-60) / 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
- Labeler
- Breckenridge Pharmaceutical, Inc.NDC labeler code 51991
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205960
- Marketing start
- Listing expires
- Identifiers
- Product ID 51991-361_194b5ce2-7d21-4617-9888-9a97b9d7690aSPL ID 194b5ce2-7d21-4617-9888-9a97b9d7690a
- 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
N451991036111followed by a unit qualifier and the quantityPackage 51991-0361-11. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 51991-361
- What is NDC 51991-361?
- 51991-361 is the product NDC for Asenapine (asenapine maleate), Asenapine maleate 10 mg/1 tablet, listed with the FDA by Breckenridge Pharmaceutical, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Asenapine (Asenapine maleate).
- What is the active ingredient?
- Asenapine maleate.
- Who is the labeler?
- Breckenridge Pharmaceutical, Inc., NDC labeler code 51991. 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 Limited | 46708-544 | 46708-0544-3146708-0544-60 |
| 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 |
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 | Breckenridge Pharmaceutical, Inc. | 51991-358 |
| Asenapineasenapine maleate | Asenapine maleate 5 mg/1 | TabletSublingual | Breckenridge Pharmaceutical, Inc. | 51991-359 |
| Asenapineasenapine maleate | Asenapine maleate 10 mg/1 | TabletSublingual | Breckenridge Pharmaceutical, Inc. | 51991-360 |
| Asenapineasenapine maleate | Asenapine maleate 2.5 mg/1 | TabletSublingual | Breckenridge Pharmaceutical, Inc. | 51991-928 |
| Asenapineasenapine maleate | Asenapine maleate 5 mg/1 | TabletSublingual | MSN LABORATORIES PRIVATE LIMITED | 69539-057 |
| 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 2.5 mg/1 | TabletSublingual | MSN LABORATORIES PRIVATE LIMITED | 69539-245 |