FDA.reportPublic FDA data

NDC 0456-2410-11 - SAPHRIS

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0456-2410
Requested NDC
0456-2410-11
Package NDCs from labels
0456-2410-10, 0456-2410-06, 0456-2410-60, 0456-2410-11, 0456-2410-63
Manufacturer
Allergan, Inc.
Effective date
2025-01-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SAPHRIS - Allergan, Inc.Allergan, Inc.2025-01-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0456-2410-06SAPHRIS1 in 1 CASETABLET122
0456-2410-06SAPHRIS10 in 1 BLISTER PACKTABLET1022
0456-2410-10SAPHRIS1 in 1 CARTONTABLET122
0456-2410-10SAPHRIS1 in 1 CASETABLET122
0456-2410-11SAPHRIS10 in 1 BLISTER PACKTABLET1022
0456-2410-60SAPHRIS6 in 1 CARTONTABLET622
0456-2410-63SAPHRIS10 in 1 CARTONTABLET1022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0456-2410SAPHRIS (ASENAPINE MALEATE) TABLET [ALLERGAN, INC.]21Current NDC, Legacy NDC, 7 package rows20250212_5429f134-839f-4ffc-9944-55f51238def8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0456-2410-06EA - Each0456-24108c648586-e483-4d87-81a4-1f1c8c039ffe12017-04-05
0456-2410-11EA - Each0456-2410710055f4-91b6-4c9c-85fa-fce5802aec4712017-04-05
0456-2410-60EA - Each0456-2410ab5f0b54-d5d3-49dd-801b-4b1d9924104012014-11-05
0456-2410-63EA - Each0456-241018c9c7f1-a65c-4cea-ad20-90b9dc22d4d112014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Asenapine MaleateACTIVE INGREDIENTCU9463U2E2SAPHRIS (ASENAPINE MALEATE) TABLET [FOREST LABORATORIES, INC.]5
AsenapineACTIVE MOIETYJKZ19V908OSAPHRIS (ASENAPINE MALEATE) TABLET [FOREST LABORATORIES, INC.]5
gelatinINACTIVE INGREDIENT2G86QN327LSAPHRIS (ASENAPINE MALEATE) TABLET [FOREST LABORATORIES, INC.]5
mannitolINACTIVE INGREDIENT3OWL53L36ASAPHRIS (ASENAPINE MALEATE) TABLET [FOREST LABORATORIES, INC.]5

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Artificial Sweetener Detox 6034ARTIFICIAL SWEETENER DETOXProfessional Complementary Health Formulas38f2ae0b-2b1f-4b49-934d-fe1556f84d932026-01-08WarningsExact identifier
unii: 96K6UQ3ZD4
ASENAPINEASENAPINESigmapharm Laboratories, LLC3512687b-d1c7-45c4-8822-3a2ad53575a52025-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859981
rxcui: 859975
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Aspartame/MSG DetoxCHELIDONIUM MAJUS, ARNICA MONTANA, PHYTOLACCA DECANDRA, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BISPHENOL A (BPA), DEXTROSE, MALTODEXTRIN, SUCRALOSE, ASPARTIC ACID, DIKETOPIPERAZINE, DOPAMINE HYDROCHLORIDE, FORMALINUM, FORMICUM ACIDUM, L-PHENYLALANINE, METHYL ALCOHOL, MONOSODIUM GLUTAMATEDeseret Biologicals, Inc.a1dc1bf3-db71-4550-a975-4f146fb940052025-03-11WarningsExact identifier
unii: 96K6UQ3ZD4
AsenapineASENAPINEAlembic Pharmaceuticals Inc.16e1cc9f-7699-49ea-b179-acb65e1623042025-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859981
rxcui: 1606337
rxcui: 859975
SAPHRISASENAPINE MALEATEAllergan, Inc.5429f134-839f-4ffc-9944-55f51238def82025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA022117
ndc (package): 0456-2410-06
ndc (package): 0456-2405-06
ndc (package): 0456-2402-60
ndc (package): 0456-2402-11
ndc (package): 0456-2402-63
ndc (package): 0456-2402-06
ndc (package): 0456-2410-10
ndc (package): 0456-2410-11
ndc (package): 0456-2410-63
ndc (package): 0456-2410-60
ndc (package): 0456-2402-10
ndc (package): 0456-2405-10
ndc (package): 0456-2405-60
ndc (package): 0456-2405-11
ndc (package): 0456-2405-63
ndc (product): 0456-2410
ndc (product): 0456-2402
ndc (product): 0456-2405
ndc11 (package): 00456241011
rxcui: 859981
rxcui: 859979
rxcui: 1606490
rxcui: 859983
rxcui: 1606337
rxcui: 859975
spl id: 9827c4dd-ffac-4022-a021-d1b15a364ecd
spl set id: 5429f134-839f-4ffc-9944-55f51238def8
unii: CU9463U2E2
AsenapineASENAPINE MALEATEBreckenridge Pharmaceutical, Inc.f5cd9abb-40e3-4cb5-a1b2-40cdba8a1c7e2024-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859981
rxcui: 1606337
rxcui: 859975
unii: CU9463U2E2
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
AsenapineASENAPINEAlembic Pharmaceuticals Limitedcf587c48-9cd2-4dc5-b0e9-21783c5633a62023-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859981
rxcui: 1606337
rxcui: 859975
AsenapineASENAPINE MALEATEMSN LABORATORIES PRIVATE LIMITED4c7a1b17-e73e-4417-a172-bfb03569d7ff2021-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 859981
rxcui: 1606337
rxcui: 859975
unii: CU9463U2E2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.