FDA.reportPublic FDA data

NDC 70710-1986-06 - Sitagliptin and metformin hydrochloride

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
70710-1986
Requested NDC
70710-1986-06
Package NDCs from labels
70710-1986-6, 70710-1986-8, 70710-1986-06
Manufacturer
Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited
Effective date
2026-08-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SITAGLIPTIN - Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences LimitedZydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited2026-08-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1986-6Sitagliptin and metformin hydrochloride60 in 1 BOTTLETABLET, FILM COATED606
70710-1986-8Sitagliptin and metformin hydrochloride180 in 1 BOTTLETABLET, FILM COATED1806

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1986SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]5Current NDC, 2 package rows20240810_4d812277-21a8-4de3-b728-e3fdd01305b5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1986-6EA - Each70710-1986fe761fda-17c9-40c0-9689-23ad5ad64ca912024-07-12

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 160 · 3,193 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
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: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEQuallent Pharmaceuticals Health LLC25be863d-490c-47f6-9ad3-c828dc43fbf02026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Sitagliptin and metformin hydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.4d812277-21a8-4de3-b728-e3fdd01305b52026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA216743
ndc (package): 70710-1987-8
ndc (package): 70710-1987-6
ndc (package): 70710-1986-8
ndc (package): 70710-1986-6
ndc (product): 70710-1987
ndc (product): 70710-1986
ndc11 (package): 70710198606
rxcui: 861769
rxcui: 861819
spl id: 6c6865d9-b997-4c50-bb00-0b188ae0d2c0
spl set id: 4d812277-21a8-4de3-b728-e3fdd01305b5
unii: QFP0P1DV7Z
unii: 786Z46389E
Sitagliptin and metformin hydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limitede07abcb1-1f0c-4cad-8405-8eedba4b8ff82026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA216743
rxcui: 861769
rxcui: 861819
unii: QFP0P1DV7Z
unii: 786Z46389E
ZITUVIMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limited0098dec4-f0e5-45d5-8aa4-5d0faf9ab1422026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA216743
rxcui: 861769
rxcui: 861819
unii: QFP0P1DV7Z
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
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

Reported adverse events (FAERS/openFDA)#

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