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 147 of 157 · 3,121 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350Geri-Care Pharmaceutical Corpf4c7eb80-d8d5-406d-90d0-9d17914d71f22022-11-24WarningsExact identifier
unii: G2M7P15E5P
4 Kids Cold and Mucus NighttimeEUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFURHyland's Inc.6f7b2585-2f0e-5938-e053-2a91aa0aa9d12022-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
4 Kids Complete Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.ef39fe3d-a42d-4baa-9199-91f664feb4322022-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
GUNA-LYMPHOAPIS MELLIFERA - CALENDULA OFFICINALIS FLOWER - CENTELLA ASIATICA - DODECAHYDROXYCYCLOHEXANE DIHYDRATE - EQUISETUM HYEMALE - FUMARIC ACID - GOLDENSEAL - GRAPHITE - JUGLANS REGIA LEAF - LEVOTHYROXINE - MAGNESIUM PHOSPHATE - MALIC ACID - MYOSOTIS ARVENSIS - PHYTOLACCA AMERICANA ROOT - SARSAPARILLA - SODIUM DIETHYL OXALACETATE - SODIUM PYRUVATE - SUS SCROFA CAPILLARY TISSUE - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - SUS SCROFA VEIN - TARAXACUM OFFICINALE -Guna spaecd11761-9b9c-4d42-9e2b-f03ba4fed8ae2022-11-14WarningsExact identifier
unii: 817L1N4CKP
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC34aa1761-d16f-4bfc-b7fa-bf1b0387e8a32022-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCd0bee456-c8cd-46a1-acb3-5313a8cddd302022-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP474e2900-43bf-4ebe-9d29-4a7adb8a94292022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Gericare Pharmaceuticals5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd2022-10-28WarningsExact identifier
unii: G2M7P15E5P
Equate ClearLAXPOLYETHYLENE GLYCOL 3350WALMART INC.c5c13378-3c08-415f-8ab4-8a18d6300ca82022-09-08WarningsExact identifier
unii: G2M7P15E5P
Hendel Periodontal and Tooth Pain ReliefSODIUM BORATE, TRIBASIC CALCIUM PHOSPHATE, MERCURIUS SOLUBILIS, AND SILICON DIOXIDEMediNatura Incf34e9f77-69fd-4c7f-9eea-2d721a4d27fb2022-08-22WarningsExact identifier
unii: ETJ7Z6XBU4
injoy constipation reliefPOLYETHYLENE GLYCOL 3350L. Perrigo Companyb2414517-04bf-4f29-951e-b867855078c32022-08-19WarningsExact identifier
unii: G2M7P15E5P
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC6b8824c0-ece0-4b15-ba71-e893d6d2bfdf2022-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Good Sense Clear LaxPOLYETHYLENE GLYCOL 3350Proficient Rx LP0858a914-4812-4e4d-82f8-ecf93d43ef3b2022-07-01WarningsExact identifier
unii: G2M7P15E5P
Metformin HClMETFORMIN HCLProficient Rx LP53361a39-cb69-483b-a4be-3a4753bf1ba62022-06-01Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
GAVILAXPOLYETHYLENE GLYCOL 3350Proficient Rx LP199d6173-3fad-49e4-88fe-bde7223ed4c32022-06-01WarningsExact identifier
unii: G2M7P15E5P
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDESolco Healthcare US, LLC.1016cad7-2198-483c-893b-e25fd397a2262022-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: 15FIX9V2JP
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LPd51f3618-4166-4925-8994-968a653ebc462022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LPd80aa4af-a8ce-4cae-b71c-05e1de8295512022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEProficient Rx LP5f243894-bda3-4fa9-97e4-209dcb389dee2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E

Reported adverse events (FAERS/openFDA)#

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