FDA.reportPublic FDA data

NDC 70710-1805-06 - ZITUVIMET 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
70710-1805
Requested NDC
70710-1805-06
Package NDCs from labels
70710-1805-6, 70710-1805-06
Manufacturer
Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited
Effective date
2025-07-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ZITUVIMET XR - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited2025-07-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1805-6ZITUVIMET XR60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1805ZITUVIMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]1Current NDC, 1 package rows20241101_2f635b36-e86a-4e53-8eaf-589917b5f342.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1805-6EA - Each70710-18057a4b317f-4bf2-4f70-a97c-79d669e671d212024-11-05

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 96 of 154 · 3,070 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.0b3d5420-d60c-8385-e063-6394a90abb6c2025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HClMETFORMIN HCLNuCare Pharmaceuticals,Inc.0b3d7c79-9a5a-a82e-e063-6394a90a3caa2025-02-03Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Brush On Block Sun Shine SPF 30 Protective Lip Oil Peony TintTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC2d490531-af36-87d0-e063-6394a90acf492025-02-03WarningsExact identifier
unii: 15FIX9V2JP
METFORMIN HYDROCHLORIDE EXTENDED RELEASEMETFORMIN HYDROCHLORIDEProficient Rx LPf1530d4f-21d9-4a4f-a814-07b180828ecd2025-02-01WarningsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP7cb47c3e-6657-4c11-8aa2-ae172e5a85292025-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
ZITUVIOSITAGLIPTINZydus Pharmaceuticals (USA) Inc.abfdea45-c0ca-41e3-a510-e89810bc9cfe2025-01-31Warnings, Adverse reactionsExact identifier
unii: QFP0P1DV7Z
PAULAS CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEPaula's Choice, Incb90658d0-e422-4265-a6ee-39c29b6c116a2025-01-31WarningsExact identifier
unii: 15FIX9V2JP
SunStation USA SPF-30 SPORT SUNSCREENZINC OXIDERENU LABORATORIES, LLC11d3c60e-238d-999e-e063-6394a90a624b2025-01-31WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE AND ZINC OXIDEDERM ASSO. MID OHIO2d04bc5d-6f11-4f56-e063-6294a90ae7552025-01-31WarningsExact identifier
unii: 15FIX9V2JP
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2d0766a1-4091-e84a-e063-6394a90a004a2025-01-31WarningsExact identifier
unii: 15FIX9V2JP
ZITUVIOSITAGLIPTINZydus Lifesciences Limitedb2da9d77-154b-48f7-8793-3f4a24dfafc62025-01-31Warnings, Adverse reactionsExact identifier
unii: QFP0P1DV7Z
SitagliptinSITAGLIPTINZydus Pharmaceuticals (USA) Inc.6a970e80-b753-48fa-9fff-87e7a50449822025-01-31Warnings, Adverse reactionsExact identifier
unii: QFP0P1DV7Z
SitagliptinSITAGLIPTINZydus Lifesciences Limitede5ac97e8-3a0b-4750-8e3f-3374125707462025-01-31Warnings, Adverse reactionsExact identifier
unii: QFP0P1DV7Z
Metformin HydrochlorideMETFORMIN HYDROCHLORIDELifsa Drugs, LLCa2385bcd-0943-4411-8658-c22b503603852025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
COVER plus CORRECT/TINTED MOISTURIZER CC CRM FAIROCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDEBluemercury5c590aed-d2f2-4478-8919-37c848752b422025-01-29WarningsExact identifier
unii: 15FIX9V2JP
LiProtect SPF 35ZINC OXIDE, TITANIUM DIOXIDEScience of Skincare0d0a2657-4098-3c60-e063-6294a90acabb2025-01-29WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBELLE MEDICAL LLC2cdc69d3-2192-7a38-e063-6294a90a257f2025-01-29WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBoxbar Beauty LLC2d04c5e7-f3aa-873f-e063-6294a90a33d22025-01-29WarningsExact identifier
unii: 15FIX9V2JP
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d63b107-cd47-d9a5-e053-2a95a90a44932025-01-28WarningsExact identifier
unii: ETJ7Z6XBU4
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2cc8f7ef-eda3-fe71-e063-6394a90a6a9a2025-01-28WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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