FDA.reportPublic FDA data

Hetlioz

Product NDC
43068-220
11-digit product format
430680220
Labeler code
43068
Product ID
43068-220_3248eef5-6bad-4844-a6f9-2f5fddd39c8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tasimelteon
Dosage form
CAPSULE
Route
ORAL
Labeler
Vanda Pharmaceuticals Inc.
Application
NDA205677
Marketing category
NDA
Marketing start
2014-04-04
Substance
TASIMELTEON
Active strength
20 mg/1
Pharmacologic classes
Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hetlioz
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TASIMELTEON20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSHS4PU80D9
Rxcui1490473, 1491624, 2468312, 2468316

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b0ceaaa0-f09f-4b6b-aa19-c4134ebad977Product name320240205

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43068-220-012020-08-14C16284748780-1ab0e2407-26ed-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use HETLIOZ safely and effectively. See full prescribing information for HETLIOZ. HETLIOZ ® (tasimelteon) capsules, for oral use HETLIOZ LQ ™ (tasimelteon) oral suspension Initial U.S. Approval: 2014
43068-220-012020-07-22C16284748780-1ab0e2407-26ed-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use HETLIOZ safely and effectively. See full prescribing information for HETLIOZ. HETLIOZ ® (tasimelteon) capsules, for oral use HETLIOZ LQ ™ (tasimelteon) oral suspension Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43068-220-01Hetlioz30 in 1 BOTTLECAPSULE3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43068-220-01EA - Each43068-22052934588-21be-43bc-8c93-2b087ff492c912014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TASIMELTEONACTIVE INGREDIENTSHS4PU80D9HETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]5
TASIMELTEONACTIVE MOIETYSHS4PU80D9HETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]5
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]5
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYHETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]5
GELATININACTIVE INGREDIENT2G86QN327LHETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHETLIOZ (TASIMELTEON) CAPSULE [VANDA PHARMACEUTICALS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43068-220HETLIOZ (TASIMELTEON) CAPSULE HETLIOZ LQ (TASIMELTEON) SUSPENSION [VANDA PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 1 package rows20221223_ca4a9b63-708e-49e9-8f9b-010625443b90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1491624Hetlioz 20 MG Oral CapsulePSNca4a9b63-708e-49e9-8f9b-010625443b9013
2468316Hetlioz LQ 4 MG/mL Oral SuspensionPSNca4a9b63-708e-49e9-8f9b-010625443b9013
1490473tasimelteon 20 MG Oral CapsulePSNca4a9b63-708e-49e9-8f9b-010625443b9013
2468312tasimelteon 4 MG/mL Oral SuspensionPSNca4a9b63-708e-49e9-8f9b-010625443b9013
1491624tasimelteon 20 MG Oral Capsule [Hetlioz]SBDca4a9b63-708e-49e9-8f9b-010625443b9013
2468316tasimelteon 4 MG/ML Oral Suspension [Hetlioz]SBDca4a9b63-708e-49e9-8f9b-010625443b9013
1490473tasimelteon 20 MG Oral CapsuleSCDca4a9b63-708e-49e9-8f9b-010625443b9013
2468312tasimelteon 4 MG/ML Oral SuspensionSCDca4a9b63-708e-49e9-8f9b-010625443b9013
1491624Hetlioz 20 MG Oral CapsuleSYca4a9b63-708e-49e9-8f9b-010625443b9013
2468316Hetlioz 4 MG/ML Oral SuspensionSYca4a9b63-708e-49e9-8f9b-010625443b9013
2468316Hetlioz LQ 4 MG/ML Oral SuspensionSYca4a9b63-708e-49e9-8f9b-010625443b9013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43068-220-014306802200130 CAPSULE in 1 BOTTLE (43068-220-01) 30 capsule2014-04-040000-00-00NoNoCurrent