FDA.reportPublic FDA data

NDC 54436-250-02 - XYOSTED

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
54436-250
Requested NDC
54436-250-02
Package NDCs from labels
54436-250-02, 54436-250-04, 54436-250-03, 54436-250-01
Manufacturer
Antares Pharma, Inc. | Bayer de Mexico, S.A. de C.V.
Effective date
2025-07-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
XYOSTED - Antares Pharma, Inc. | Bayer de Mexico, S.A. de C.V.Antares Pharma, Inc. | Bayer de Mexico, S.A. de C.V.2025-07-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54436-250-01XYOSTED1 in 1 CARTONINJECTION116
54436-250-02XYOSTED0.5 mL in 1 SYRINGEINJECTION0.516
54436-250-03XYOSTED0.5 mL in 1 SYRINGEINJECTION0.516
54436-250-04XYOSTED4 in 1 CARTONINJECTION416

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54436-250XYOSTED (TESTOSTERONE ENANTHATE) INJECTION [ANTARES PHARMA, INC.]12Current NDC, Legacy NDC, 4 package rows20250406_8a3d204c-be26-49e0-8599-0ac12a272e81.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54436-250-02ML - Milliliter54436-2504fa6e167-bb60-4c91-ba1f-c23e58ca513612018-11-06
54436-250-04ML - Milliliter54436-250d8e04683-24c0-4eb4-81f5-3ac2566d728f12018-11-06

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 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TESTOSTERONE ENANTHATETESTOSTERONE ENANTHATEEugia US LLC82a98132-9d5f-40a5-8c4f-f52f2a5de60e2026-06-12Warnings, Adverse reactionsExact identifier
unii: 7Z6522T8N9
TESTOSTERONE ENANTHATETESTOSTERONE ENANTHATEHikma Pharmaceuticals USA Inc.e89d6458-428c-4256-97a3-f1fa851293c12026-05-08Warnings, Adverse reactionsExact identifier
unii: 7Z6522T8N9
Body Oil for Stretch MarksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL ,TOCOPHEROL,ADANSONIA DIGITATA SEED 0IL,MORINGA OLEIFERA SEED 0IL,THEOBROMA CACAO (COCOA) SEED BUTTER,ECHIUM PLANTAGINEUM SEED OIL,SESAMUM INDICUM (SESAME) SEED 0ILDongguan Xiaogoubeige trading company Ltd.496af9a1-7249-622f-e063-6394a90aa2842026-01-27WarningsExact identifier
unii: QX10HYY4QV
Bone LiquescenceTARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, CALCAREA MURIATICA, EQUISETUM ARVENSE, JUGLANS NIGRA, SESAME OIL, CALCAREA SULPHURICA, HEPAR (BOVINE), KIDNEY (BOVINE), MEDULLA OSSIS SUIS, MENADIONE, THYROIDINUM (BOVINE), VITAMIN A, VITAMIN D3 (CHOLECALCIFEROL) , CALCAREA PHOSPHORICA, CALCAREA CARBONICA, CALCAREA FLUORICA MANGANUM METALLICUM, NICCOLUM METALLICUM, MAGNESIA CARBONICANutritional Specialties, Inc.4c86b348-5808-4d6d-b283-00ab37557fd72025-11-25WarningsExact identifier
unii: QX10HYY4QV
Bone LiquescenceTARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, CALCAREA MURIATICA, EQUISETUM ARVENSE, JUGLANS NIGRA, SESAME OIL, CALCAREA SULPHURICA, HEPAR (BOVINE), KIDNEY (BOVINE), MEDULLA OSSIS SUIS, MENADIONE, THYROIDINUM (BOVINE), VITAMIN A, VITAMIN D3, CALCAREA PHOSPHORICA, CALCAREA CARBONICA, CALCAREA FLUORICA, MANGANUM METALLICUM, NICCOLUM METALLICUM, MAGNESIUM METALLICUMNutritional Specialties, Inc.28c244ca-7a99-4750-9942-32fdf4d3dac92025-10-06WarningsExact identifier
unii: QX10HYY4QV
XYOSTEDTESTOSTERONE ENANTHATEAntares Pharma, Inc.8a3d204c-be26-49e0-8599-0ac12a272e812025-07-01Warnings, Adverse reactionsExact identifier
application number: NDA209863
ndc (package): 54436-250-02
ndc (package): 54436-250-01
ndc (package): 54436-200-02
ndc (package): 54436-200-03
ndc (package): 54436-275-03
ndc (package): 54436-275-04
ndc (package): 54436-200-01
ndc (package): 54436-275-02
ndc (package): 54436-250-03
ndc (package): 54436-250-04
ndc (package): 54436-200-04
ndc (package): 54436-275-05
ndc (package): 54436-200-05
ndc (package): 54436-275-01
ndc (product): 54436-250
ndc (product): 54436-275
ndc (product): 54436-200
ndc11 (package): 54436025002
rxcui: 2099686
rxcui: 2099697
rxcui: 2099689
rxcui: 2099695
rxcui: 2099681
rxcui: 2099691
spl id: c8d74eb6-fa94-446a-8307-091436a536dc
spl set id: 8a3d204c-be26-49e0-8599-0ac12a272e81
unii: 7Z6522T8N9
Body oil for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL ,TOCOPHEROL,ADANSONIA DIGITATA SEED 0IL,MORINGA OLEIFERA SEED 0IL,THEOBROMA CACAO (COCOA) SEED BUTTER,ECHIUM PLANTAGINEUM SEED OIL,SESAMUM INDICUM (SESAME) SEED 0ILGuangzhou Senmai Biotechnology Co.1daeb2e8-f18c-06c3-e063-6294a90a63852025-01-08WarningsExact identifier
unii: QX10HYY4QV
Thyroid TonicACACIA ARABICA, OLEUM OLEA EUROPAEA, SESAME OIL, FUCUS VESICULOSUS 3X, IODIUM, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAGE OIL, CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), HYDROFLUORICUM ACIDUMEnergique, Inc.aeca8e0e-12e6-44d0-a709-401d137f7cf32024-10-31WarningsExact identifier
unii: QX10HYY4QV
Bone LiquescenceTARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, CALCAREA MURIATICA, EQUISETUM ARVENSE, JUGLANS NIGRA, SESAME OIL, CALCAREA SULPHURICA, HEPAR SUIS, KIDNEY (SUIS), MEDULLA OSSIS SUIS, MENADIONE, THYROIDINUM (BOVINE), VITAMIN A, VITAMIN D3, CALCAREA PHOSPHORICA, CALCAREA CARBONICA, CALCAREA FLUORICA, MANGANUM METALLICUM, NICCOLUM METALLICUM, MAGNESIUM METALLICUMNutritional Specialties, Inc.5d323e16-e9a5-4933-9593-285c7b3c54ce2023-11-17WarningsExact identifier
unii: QX10HYY4QV

Reported adverse events (FAERS/openFDA)#

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