FDA.reportPublic FDA data

NDC 50090-5502-01 - JANUMET

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
50090-5502
Requested NDC
50090-5502-01
Package NDCs from labels
50090-5502-0, 50090-5502-1, 50090-5502-01
Manufacturer
A-S Medication Solutions
Effective date
2026-07-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
JANUMET - A-S Medication SolutionsA-S Medication Solutions2026-07-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5502-0JANUMET60 in 1 BOTTLETABLET, FILM COATED609
50090-5502-1JANUMET180 in 1 BOTTLETABLET, FILM COATED1809

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5502JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Current NDC, 2 package rows20230722_c603b844-2019-4ef4-8385-7bc3f96a2565.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5502-0EA - Each50090-55020d7b69c7-044b-47fe-888b-b8a4935970dd12023-08-08
50090-5502-1EA - Each50090-5502141808dc-dfb6-4427-9869-598feb114c6b12023-08-08

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 6 of 125 · 2,488 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAdvanced Rx of Tennessee, LLC5647230e-5bc6-1802-e063-6394a90a27242026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEA-S Medication Solutionsb55ee3d9-7f0b-4dd9-9213-fbc69f09f5672026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA022044
rxcui: 861821
rxcui: 2709491
unii: TS63EW8X6F
unii: 786Z46389E
JANUVIASITAGLIPTINA-S Medication Solutions62c4f58b-2b28-4825-aeb6-213ab9b7a0262026-07-08Warnings, Adverse reactionsExact identifier
unii: TS63EW8X6F
Saxagliptin and Metformin HydrochlorideSAXAGLIPTIN AND METFORMIN HYDROCHLORIDEDr.Reddys Laboratories Inc65884427-4dde-63bb-a23f-36a7779c0a6b2026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
JANUVIASITAGLIPTINA-S Medication Solutions194c3718-5eb5-4cf5-85d0-2bb1ed8293b82026-07-08Warnings, Adverse reactionsExact identifier
unii: TS63EW8X6F
JANUVIASITAGLIPTINA-S Medication Solutions4a758211-8af1-449b-9a10-f3d67d7ec8b62026-07-08Warnings, Adverse reactionsExact identifier
unii: TS63EW8X6F
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAurobindo Pharma Limitedfc466c46-abaa-4675-aef2-4b1a1adfd9122026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
JANUVIASITAGLIPTINA-S Medication Solutions1b03c82f-b52e-4092-b9dc-f2c9b0d6ab402026-07-08Warnings, Adverse reactionsExact identifier
unii: TS63EW8X6F
JANUVIASITAGLIPTINA-S Medication Solutionseb81a45f-05b8-49de-99ce-5089bd360d9b2026-07-08Warnings, Adverse reactionsExact identifier
unii: TS63EW8X6F
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Polyvinyl AlcoholPOLYVINYL ALCOHOLAvPAKf18b61da-4033-341a-e053-2a95a90a8ebf2026-07-07WarningsExact identifier
unii: 532B59J990
METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.14f3091c-f243-4364-b433-727c7d4ef8d52026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin hydrochlorideMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.17050df5-9e95-4e1b-ac75-34add289b1392026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.b38213bb-d663-4c95-a1b2-96c23ee5be092026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
Glyburide and Metformin HydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDERising Pharma Holdings, Inc.372af566-d6ec-446f-88db-0b4cc83b577f2026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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