Prescription drug · NDA
Bysanti (Milsaperidone) NDC 43068-912
Kit · Oral · Vanda Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43068-912-08 | 4306809120843068091208 | 2 CARTON in 1 BLISTER PACK (43068-912-08) / 1 KIT in 1 CARTONMarketed from Jul 1, 2026 · Sample package |
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)
- Bysanti
- Generic name (nonproprietary)
- milsaperidone
- Dosage form
- Kit
- Route
- Oral
- Labeler
- Vanda Pharmaceuticals Inc.NDC labeler code 43068
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 220358
- Marketing start
- Listing expires
- Identifiers
- Product ID 43068-912_d49d59a7-1bab-44a6-9d19-4b5635a3f378SPL ID d49d59a7-1bab-44a6-9d19-4b5635a3f378SPL set ID 254a1c01-4a4c-4bdd-85d6-1f23f2e4e6f8RxCUI 2745770, 2745776, 2745778, 2745780, 2745782, 2745784, 2745786, 2745788, 2745790, 2745792, 2745794, 2745796, 2745798, 2745800, 2746018, 2746019, 2746020, 2746021, 2746022, 2746023UNII 7SV1ZOG031
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N443068091208followed by a unit qualifier and the quantityPackage 43068-0912-08. 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)
BYSANTI ™ is indicated for the: Treatment of schizophrenia in adults [see Clinical Studies (14.1) ] . Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults [see Clinical Studies (14.2) ] . BYSANTI is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. ( 1 , 14.1 ) Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. ( 1 , 14.2 )
Excerpt only. Read the full label for complete information.
About NDC 43068-912
- What is NDC 43068-912?
- 43068-912 is the product NDC for Bysanti (milsaperidone) kit, listed with the FDA by Vanda Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bysanti (Milsaperidone).
- Who is the labeler?
- Vanda Pharmaceuticals Inc., NDC labeler code 43068. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bysanti?
- 15 other product NDCs are listed under this name. See all Bysanti NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bysanti products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bysantimilsaperidone | Milsaperidone 1 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-701 | 43068-0701-02 |
| Bysantimilsaperidone | Milsaperidone 2 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-702 | 43068-0702-02 |
| Bysantimilsaperidone | Milsaperidone 4 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-704 | 43068-0704-02 |
| Bysantimilsaperidone | Milsaperidone 6 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-706 | 43068-0706-02 |
| Bysantimilsaperidone | Milsaperidone 8 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-708 | 43068-0708-02 |
| Bysantimilsaperidone | Milsaperidone 10 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-710 | 43068-0710-02 |
| Bysantimilsaperidone | Milsaperidone 12 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-712 | 43068-0712-02 |
| Bysantimilsaperidone | — | KitOral | Vanda Pharmaceuticals Inc. | 43068-713 | 43068-0713-04 |
| Bysantimilsaperidone | — | KitOral | Vanda Pharmaceuticals Inc. | 43068-714 | 43068-0714-04 |
| Bysantimilsaperidone | — | KitOral | Vanda Pharmaceuticals Inc. | 43068-715 | 43068-0715-03 |
Other NDCs under NDA 220358
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 |
|---|---|---|---|---|
| Bysantimilsaperidone | Milsaperidone 1 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-701 |
| Bysantimilsaperidone | Milsaperidone 2 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-702 |
| Bysantimilsaperidone | Milsaperidone 4 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-704 |
| Bysantimilsaperidone | Milsaperidone 6 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-706 |
| Bysantimilsaperidone | Milsaperidone 8 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-708 |
| Bysantimilsaperidone | Milsaperidone 10 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-710 |
| Bysantimilsaperidone | Milsaperidone 12 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-712 |
| Bysantimilsaperidone | — | KitOral | Vanda Pharmaceuticals Inc. | 43068-713 |
| Bysantimilsaperidone | — | KitOral | Vanda Pharmaceuticals Inc. | 43068-714 |
| Bysantimilsaperidone | — | KitOral | Vanda Pharmaceuticals Inc. | 43068-715 |
| Bysantimilsaperidone | Milsaperidone 1 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-908 |
| Bysantimilsaperidone | Milsaperidone 6 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-910 |
| Bysantimilsaperidone | Milsaperidone 8 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-911 |
| Bysantimilsaperidone | — | KitOral | Vanda Pharmaceuticals Inc. | 43068-913 |
| Bysantimilsaperidone | — | KitOral | Vanda Pharmaceuticals Inc. | 43068-914 |