FDA.reportPublic FDA data

NDC 50090-3472-01 - JANUVIA

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
50090-3472
Requested NDC
50090-3472-01
Package NDCs from labels
50090-3472-1, 50090-3472-0, 50090-3472-01
Manufacturer
A-S Medication Solutions
Effective date
2026-07-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
JANUVIA - A-S Medication SolutionsA-S Medication Solutions2026-07-08HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-02-07These highlights do not include all the information needed to use JANUVIA safely and effectively. See full prescribing information for JANUVIA. JANUVIA ® (sitagliptin) tablets, for oral use Initial U.S. Approval: 2006
2023-02-07These highlights do not include all the information needed to use JANUVIA safely and effectively. See full prescribing information for JANUVIA. JANUVIA ® (sitagliptin) tablets, for oral use Initial U.S. Approval: 2006
2023-01-30These highlights do not include all the information needed to use JANUVIA safely and effectively. See full prescribing information for JANUVIA. JANUVIA ® (sitagliptin) tablets, for oral use Initial U.S. Approval: 2006
2023-01-30These highlights do not include all the information needed to use JANUVIA safely and effectively. See full prescribing information for JANUVIA. JANUVIA ® (sitagliptin) tablets, for oral use Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3472-0JANUVIA30 in 1 BOTTLETABLET, FILM COATED3011
50090-3472-1JANUVIA90 in 1 BOTTLETABLET, FILM COATED9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3472JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 2 package rows20230828_194c3718-5eb5-4cf5-85d0-2bb1ed8293b8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3472-0EA - Each50090-34724d265d53-bad8-428c-84c0-3cc7b1824e6512023-10-16
50090-3472-1EA - Each50090-3472d0e231d7-8821-4f9e-9699-fc6e443c6a3612021-09-07

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 3 of 108 · 2,142 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEA-S Medication Solutionsb55ee3d9-7f0b-4dd9-9213-fbc69f09f5672026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: TS63EW8X6F
JANUVIASITAGLIPTINA-S Medication Solutions62c4f58b-2b28-4825-aeb6-213ab9b7a0262026-07-08Warnings, Adverse reactionsExact identifier
application number: NDA021995
rxcui: 2709603
rxcui: 665036
unii: TS63EW8X6F
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
application number: NDA021995
ndc (package): 50090-3472-0
ndc (package): 50090-3472-1
ndc (product): 50090-3472
ndc11 (package): 50090347201
rxcui: 665044
rxcui: 2709608
spl id: 5e9c2adc-02b6-452b-8c25-12cdaf989152
spl set id: 194c3718-5eb5-4cf5-85d0-2bb1ed8293b8
unii: TS63EW8X6F
JANUVIASITAGLIPTINA-S Medication Solutions4a758211-8af1-449b-9a10-f3d67d7ec8b62026-07-08Warnings, Adverse reactionsExact identifier
application number: NDA021995
rxcui: 665040
rxcui: 2709612
unii: TS63EW8X6F
JANUVIASITAGLIPTINA-S Medication Solutions1b03c82f-b52e-4092-b9dc-f2c9b0d6ab402026-07-08Warnings, Adverse reactionsExact identifier
application number: NDA021995
rxcui: 665040
rxcui: 2709612
unii: TS63EW8X6F
JANUVIASITAGLIPTINA-S Medication Solutionseb81a45f-05b8-49de-99ce-5089bd360d9b2026-07-08Warnings, Adverse reactionsExact identifier
application number: NDA021995
rxcui: 665044
rxcui: 2709608
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
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
unii: 1K09F3G675
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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