FDA.reportPublic FDA data

FANAPT

Product NDC
43068-106
11-digit product format
430680106
Labeler code
43068
Product ID
43068-106_2609a5b3-d7ec-48a9-a32b-54a9b207f9aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ILOPERIDONE
Dosage form
TABLET
Route
ORAL
Labeler
Vanda Pharmaceuticals Inc.
Application
NDA022192
Marketing category
NDA
Marketing start
2016-07-01
Substance
ILOPERIDONE
Active strength
6 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FANAPT
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ILOPERIDONE6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVPO7KJ050N
Rxcui848722, 848726, 848728, 848730, 848732, 848734, 848736, 848738, 848740, 848742, 848744, 848746, 848748, 848750, 848751, 848752, 2714234, 2714235, 2720356, 2720357

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c2441bbe-3ea0-4d2c-96a6-138bc08a4e8cProduct name220170213

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43068-106-02FANAPT60 in 1 BOTTLETABLET6035

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43068-106FANAPT (ILOPERIDONE) TABLET FANAPT (ILOPERIDONE) KIT [VANDA PHARMACEUTICALS INC.]33Current NDC, Legacy NDC, 1 package rows20250514_33f60b40-3fca-11de-8f56-0002a5d5c51b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848752{2 (iloperidone 1 MG Oral Tablet [Fanapt]) / 2 (iloperidone 2 MG Oral Tablet [Fanapt]) / 2 (iloperidone 4 MG Oral Tablet [Fanapt]) / 2 (iloperidone 6 MG Oral Tablet [Fanapt]) } Pack [Fanapt Titration Pack]BPCK33f60b40-3fca-11de-8f56-0002a5d5c51b35
2714235{4 (iloperidone 1 MG Oral Tablet [Fanapt]) / 2 (iloperidone 2 MG Oral Tablet [Fanapt]) / 2 (iloperidone 6 MG Oral Tablet [Fanapt]) } Pack [Fanapt Titration Pack C]BPCK33f60b40-3fca-11de-8f56-0002a5d5c51b35
2720357{6 (iloperidone 1 MG Oral Tablet [Fanapt]) / 2 (iloperidone 2 MG Oral Tablet [Fanapt]) / 2 (iloperidone 6 MG Oral Tablet [Fanapt]) / 2 (iloperidone 8 MG Oral Tablet [Fanapt]) } Pack [Fanapt Titration Pack B]BPCK33f60b40-3fca-11de-8f56-0002a5d5c51b35
848751{2 (iloperidone 1 MG Oral Tablet) / 2 (iloperidone 2 MG Oral Tablet) / 2 (iloperidone 4 MG Oral Tablet) / 2 (iloperidone 6 MG Oral Tablet) } PackGPCK33f60b40-3fca-11de-8f56-0002a5d5c51b35
2714234{4 (iloperidone 1 MG Oral Tablet) / 2 (iloperidone 2 MG Oral Tablet) / 2 (iloperidone 6 MG Oral Tablet) } PackGPCK33f60b40-3fca-11de-8f56-0002a5d5c51b35
2720356{6 (iloperidone 1 MG Oral Tablet) / 2 (iloperidone 2 MG Oral Tablet) / 2 (iloperidone 6 MG Oral Tablet) / 2 (iloperidone 8 MG Oral Tablet) } PackGPCK33f60b40-3fca-11de-8f56-0002a5d5c51b35
848726Fanapt 1 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848730Fanapt 10 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848734Fanapt 12 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848738Fanapt 2 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848742Fanapt 4 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848746Fanapt 6 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848750Fanapt 8 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848752Fanapt Titration Pack APSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
2720357Fanapt Titration Pack BPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
2714235Fanapt Titration Pack CPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848722iloperidone 1 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848751iloperidone 1 MG Oral Tablet (2) / iloperidone 2 MG Oral Tablet (2) / iloperidone 4 MG Oral Tablet (2) / iloperidone 6 MG Oral Tablet (2) Titration Pack APSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
2714234iloperidone 1 MG Oral Tablet (4) / iloperidone 2 MG Oral Tablet (2) / iloperidone 6 MG Oral Tablet (2) Titration Pack CPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
2720356iloperidone 1 MG Oral Tablet (6) / iloperidone 2 MG Oral Tablet (2) / iloperidone 6 MG Oral Tablet (2) / iloperidone 8 MG Oral Tablet (2) Titration Pack BPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848728iloperidone 10 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848732iloperidone 12 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848736iloperidone 2 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848740iloperidone 4 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848744iloperidone 6 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848748iloperidone 8 MG Oral TabletPSN33f60b40-3fca-11de-8f56-0002a5d5c51b35
848726iloperidone 1 MG Oral Tablet [Fanapt]SBD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848730iloperidone 10 MG Oral Tablet [Fanapt]SBD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848734iloperidone 12 MG Oral Tablet [Fanapt]SBD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848738iloperidone 2 MG Oral Tablet [Fanapt]SBD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848742iloperidone 4 MG Oral Tablet [Fanapt]SBD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848746iloperidone 6 MG Oral Tablet [Fanapt]SBD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848750iloperidone 8 MG Oral Tablet [Fanapt]SBD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848722iloperidone 1 MG Oral TabletSCD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848728iloperidone 10 MG Oral TabletSCD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848732iloperidone 12 MG Oral TabletSCD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848736iloperidone 2 MG Oral TabletSCD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848740iloperidone 4 MG Oral TabletSCD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848744iloperidone 6 MG Oral TabletSCD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848748iloperidone 8 MG Oral TabletSCD33f60b40-3fca-11de-8f56-0002a5d5c51b35
848726Fanapt 1 MG Oral TabletSY33f60b40-3fca-11de-8f56-0002a5d5c51b35
848730Fanapt 10 MG Oral TabletSY33f60b40-3fca-11de-8f56-0002a5d5c51b35
848734Fanapt 12 MG Oral TabletSY33f60b40-3fca-11de-8f56-0002a5d5c51b35
848738Fanapt 2 MG Oral TabletSY33f60b40-3fca-11de-8f56-0002a5d5c51b35
848742Fanapt 4 MG Oral TabletSY33f60b40-3fca-11de-8f56-0002a5d5c51b35
848746Fanapt 6 MG Oral TabletSY33f60b40-3fca-11de-8f56-0002a5d5c51b35
848750Fanapt 8 MG Oral TabletSY33f60b40-3fca-11de-8f56-0002a5d5c51b35
848752Fanapt Titration Pack ASY33f60b40-3fca-11de-8f56-0002a5d5c51b35
2720357Fanapt Titration Pack BSY33f60b40-3fca-11de-8f56-0002a5d5c51b35
2714235Fanapt Titration Pack CSY33f60b40-3fca-11de-8f56-0002a5d5c51b35
2714234iloperidone 1 MG Oral Tablet (4) / iloperidone 2 MG Oral Tablet (2) / iloperidone 6 MG Oral Tablet (2) Titration Pack CSY33f60b40-3fca-11de-8f56-0002a5d5c51b35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43068-106-024306801060260 TABLET in 1 BOTTLE (43068-106-02) 60 tablet2016-07-010000-00-00NoNoCurrent