Prescription drug · NDA
Fanapt (iloperidone) NDC 43068-901
Iloperidone 6 mg/1 · Tablet · Oral · Vanda Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43068-901-14 | 43068090114 | 14 TABLET in 1 BOTTLE (43068-901-14)Marketed from Sep 24, 2018 · 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)
- Fanapt
- Generic name (nonproprietary)
- iloperidone
- Active ingredients
- Iloperidone — 6 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Vanda Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022192
- Marketing start
- Listing expires
- Identifiers
- Product ID 43068-901_2609a5b3-d7ec-48a9-a32b-54a9b207f9aaSPL ID 2609a5b3-d7ec-48a9-a32b-54a9b207f9aaSPL set ID 33f60b40-3fca-11de-8f56-0002a5d5c51bRxCUI 848722, 848726, 848728, 848730, 848732, 848734, 848736, 848738, 848740, 848742, 848744, 848746, 848748, 848750, 848751, 848752, 2714234, 2714235, 2720356, 2720357UNII VPO7KJ050NUPC 0343068108029, 0343068110022, 0343068101020, 0343068106025, 0343068112026, 0343068104021, 0343068102027
- 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N443068090114followed by a unit qualifier and the quantityPackage 43068-0901-14. 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)
FANAPT ® is indicated for: 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) ] . FANAPT 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.
Other NDCs under NDA 022192
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 |
|---|---|---|---|---|
| Fanaptiloperidone | Iloperidone 1 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-905 |
| Fanaptiloperidone | — | KitOral | Vanda Pharmaceuticals Inc. | 43068-906 |
| Fanaptiloperidone | — | KitOral | Vanda Pharmaceuticals Inc. | 43068-907 |
| Fanaptiloperidone | Iloperidone 6 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-106 |
| Fanaptiloperidone | Iloperidone 1 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-101 |
| Fanaptiloperidone | Iloperidone 2 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-102 |
| Fanaptiloperidone | Iloperidone 4 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-104 |
| Fanaptiloperidone | — | KitOral | Vanda Pharmaceuticals Inc. | 43068-113 |
| Fanaptiloperidone | Iloperidone 8 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-108 |
| Fanaptiloperidone | Iloperidone 10 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-110 |
| Fanaptiloperidone | Iloperidone 12 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-112 |
| Fanaptiloperidone | — | KitOral | Vanda Pharmaceuticals Inc. | 43068-114 |
| Fanaptiloperidone | — | KitOral | Vanda Pharmaceuticals Inc. | 43068-115 |
| Fanaptiloperidone | Iloperidone 8 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-902 |
| Fanaptiloperidone | — | KitOral | Vanda Pharmaceuticals Inc. | 43068-903 |
| Fanaptiloperidone | Iloperidone 2 mg/1 | TabletOral | Vanda Pharmaceuticals Inc. | 43068-904 |