FDA.reportPublic FDA data

NDC 50090-5504-01 - JANUMET XR

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
50090-5504
Requested NDC
50090-5504-01
Package NDCs from labels
50090-5504-1, 50090-5504-0, 50090-5504-01
Manufacturer
A-S Medication Solutions
Effective date
2023-06-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
JANUMET XR - A-S Medication SolutionsA-S Medication Solutions2023-06-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5504-0JANUMET XR60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE607
50090-5504-1JANUMET XR180 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1807

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5504JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]7Current NDC, 2 package rows20230623_90c0244b-afb3-4e69-b79f-486d002ca432.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5504-0EA - Each50090-55042c8f21bd-d64f-47c7-883e-982e74e48cac12023-07-06
50090-5504-1EA - Each50090-5504d179abe2-0a16-4712-95a6-c7e9288688b912023-07-06

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 5 of 155 · 3,089 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph-Tone IIIADENOSINUM CYCLOPHOSPHORICUM, ARNICA, BOLDO, CALC IOD, CALENDULA, CARTILAGO SUIS, CEANOTHUS, COENZYME A, ECHINACEA, HAMAMELIS, HEPAR SULPH CALC, HYPOTHALAMUS, NADIDUM, NAJA, NAT SULPHURICUM, PHASEOLUS, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PYROGENIUM, SILICEA, SULPHUR, THUJA OCC, THYROIDINUM, VISCUMEnergetix Corporation4c9ae54c-ce7d-4276-add7-2922a8f0e3102026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
MetabopathADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM,Energetix Corporation58bfe670-d308-45a2-8046-7897b62214522026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Vac-ChordALUMINA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BOLDO, CALCAREA CARBONICA, CARDUUS MARIANUS, CHAMOMILLA, CHELIDONIUM MAJUS, ECHINACEA, HYDRASTIS CANADENSIS, LECITHIN, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MORBILLINUM, PERTUSSINUM, PHYTOLACCA DECANDRA, PYROGENIUM, RHUS TOX, SILICEA, SULPHUR, TARAXACUM OFFICINALE, THUJA OCCIDENTALIS, THYROIDINUM.Energetix Corporation880ea1e6-8d4d-486e-9a8f-9d3158a996672026-08-11WarningsExact identifier
unii: LMI26O6933
unii: ETJ7Z6XBU4
Tox-ChordALFALFA, ALUMINA, BENZOICUM AC, CARBONEUM, CETRARIA, FOLLICULINUM, FUCUS, FUMARICUM AC, HEPAR SUIS, KALI CARB, KREOSOTUM, NAT MUR, PARAFFINUM, PETROLEUM, PHOSPHORICUM AC, PHOS, PIX LIQUIDA, PLANTAGO, PLUMB MET, PULSATILLA, RADIUM BROM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM, TABACUM, TEREBINTHINA, THYROIDINUM, TRITICUM, ZINC OXYD.Energetix Corporationb06b4794-e5bb-4ccd-87fd-37afca7b0f982026-08-11WarningsExact identifier
unii: LMI26O6933
unii: ETJ7Z6XBU4
Thyro-ChordHOMEOPATHIC LIQUIDEnergetix Corporation6655b504-dfa8-46df-9d3a-b7fa4078207e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Para-ChordHOMEOPATHIC LIQUIDEnergetix Corporation9f8f646e-634a-47ff-b208-b2249d685e552026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
MycoCan-ChordALUMINA, AVENA SATIVA, BORAX, CANDIDA ALBICANS, CARBOLICUM ACIDUM, CEANOTHUS AMERICANUS, ECHINACEA, GAULTHERIA PROCUMBENS, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, LINUM USITATISSIMUM, LITHIUM CARBONICUM, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SARCOLACTICUM ACIDUM, SEPIA, SILICEA, SOLIDAGO VIRGAUREA, TELLURIUM METALLICUM, TEUCRIUM MARUM, ZINCUM METALLICUMEnergetix Corporation227199f8-a45e-44ff-892d-ade4fefea3542026-08-11WarningsExact identifier
unii: LMI26O6933
unii: ETJ7Z6XBU4
Metal-ChordALLIUM CEPA, ALLIUM SATIVUM, ALPHA-LIPOICUM ACIDUM, ALUMINA, ARSENICUM METALLICUM, BERBERIS VULGARIS, CADMIUM METALLICUM, CARDUUS MARIANUS, CETRARIA ISLANDICA, CUPRUM METALLICUM, CYSTEINUM, GLYCYRRHIZA GLABRA, HEPAR SUIS, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NUX VOMICA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PYRIDOXINUM HYDROCHLORICUM, SELENIUM METALLICUM, STILLINGIA SYLVATICA, THYROIDINUM, TRIFOLIUM PRATENSE, ZINGIBER OFFICINALEEnergetix Corporationea4d26a8-acf2-46ed-9a69-df7764cc4cfd2026-08-11WarningsExact identifier
unii: LMI26O6933
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLCd19c7ed0-ad5c-426e-b2df-722508f97d672026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: TS63EW8X6F
unii: 786Z46389E
Synjardy XREMPAGLIFLOZIN, METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.8006ba29-ee3a-f852-a9bb-c8ec9b41cf662026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
XIGDUO XRDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEAstraZeneca Pharmaceuticals LPac8a0f7b-9f69-4495-abbc-3a47cd75a8592026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350The Fresh Test, LLCcb8e182f-c23f-4f8d-9c09-24e19b2e914e2026-08-05WarningsExact identifier
unii: G2M7P15E5P
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepackc1bfc7b5-c7e0-4353-b772-05d463c128862026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
ROROBELL WAWA Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEROROBELL58336a0d-49dd-ef13-e063-6394a90a38c12026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.1e8136e0-cc98-41e4-ad4b-a8fc27fb4daa2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.4d087f00-580b-4b9d-80d9-f97930153e722026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.5d8d654a-9bb4-4c87-ab43-c21c4e8747082026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Silicea 6XSILICON DIOXIDEHyland's Inc.db4be3c1-aa7e-24a2-e053-2a95a90a0c662026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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