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 4 of 158 · 3,151 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
KAZANOALOGLIPTIN AND METFORMIN HYDROCHLORIDETakeda Pharmaceuticals America, Inc.83cb7914-a683-47bb-a713-f2bc6a596bd22026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Preferred Pharmaceuticals Inc.cccbe459-813d-4668-8cd2-76be82906a322026-08-17WarningsExact identifier
unii: G2M7P15E5P
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
Sitagliptin and Metformin HydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEGolden State Medical Supply, Inc.58f0e875-5d9b-be0b-e063-6394a90a53452026-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: TS63EW8X6F
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEQuallent Pharmaceuticals Health LLC25be863d-490c-47f6-9ad3-c828dc43fbf02026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
SitagliptinSITAGLIPTINGolden State Medical Supply, Inc.58e23b30-451c-f451-e063-6394a90a35a72026-08-12Warnings, Adverse reactionsExact identifier
unii: TS63EW8X6F
Sitagliptin and metformin hydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.4d812277-21a8-4de3-b728-e3fdd01305b52026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Sitagliptin and metformin hydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limitede07abcb1-1f0c-4cad-8405-8eedba4b8ff82026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
ZITUVIMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limited0098dec4-f0e5-45d5-8aa4-5d0faf9ab1422026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
SEGLUROMETERTUGLIFLOZIN AND METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLCa6aeb99a-ce49-4125-90ce-642df3f1ebad2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
JANUMET XRSITAGLIPTIN AND METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLC64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b502026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA202270
ndc (product): 0006-0080
rxcui: 2709482
rxcui: 1243843
rxcui: 2709470
rxcui: 1243833
rxcui: 2709477
rxcui: 1243848
spl id: 44f3c6c6-160a-4cc8-8961-b4f7200b5ce5
spl set id: 64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50
unii: TS63EW8X6F
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDERedpharm Drug58bec665-b648-6baf-e063-6394a90a1cbb2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.e22a8545-86a6-439e-a758-29c4d6ed8bfe2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Agri-ChordARSENICUM ALB, BELLADONNA, CALC CARB, CEANOTHUS, CHELIDONIUM MAJ, CUPRUM SULPH, FUMARICUM AC, GALIUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, KALI IOD, LYCOPODIUM, PANCREAS SUIS, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, PHYTOLACCA, SARSAPARILLA, SILICEA, SULPHUR, THYROIDINUM, TRIFOLIUM PRAT, XANTHOXYLUM, ZINC PHOSEnergetix Corporation9eb50e9a-3528-4809-bd76-47d99ef03f0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Drainage-ToneCALCAREA IODATA, CAPSICUM ANNUUM, COENZYME A, ECHINACEA ANGUSTIFOLIA, EQUISETUM ARVENSE, HYDRASTIS CANADENSIS, NADIDUM, NITRICUM ACIDUM, OLEUM MORRHUAE, PETROSELINUM SATIVUM, PHYTOLACCA DECANDRA, SCROPHULARIA NODOSA, SILICEA, SINAPIS ALBA, THUJA OCCIDENTALIS.Energetix Corporation296b455e-27c5-4f6e-929d-c4ee75b7fb0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
HypothalmapathGELSEMIUM, GINKGO, GLYCYRRHIZA, HYDROCOTYLE, HYPOTHALAMUS, PETROSELINUM, PITUITARUM POSTERIUM, PYRIDOXINUM HYDROCHLORICUM, SENNA, SILICEAEnergetix Corporation3c4e2867-4d75-416b-9f3d-e6e500e46f6f2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: LMI26O6933
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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