FDA.reportPublic FDA data

NDC 33342-409-66 - Dapagliflozin 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
33342-409
Requested NDC
33342-409-66
Package NDCs from labels
33342-409-07, 33342-409-09, 33342-409-10, 33342-409-15, 33342-409-66, 33342-409-06
Manufacturer
Macleods Pharmaceuticals Limited
Effective date
2026-09-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dapagliflozin and Metformin Hydrochloride - Macleods Pharmaceuticals LimitedMacleods Pharmaceuticals Limited2026-09-16Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-409-06Dapagliflozin and Metformin Hydrochloride3 in 1 CARTONTABLET, EXTENDED RELEASE31
33342-409-07Dapagliflozin and Metformin Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE301
33342-409-09Dapagliflozin and Metformin Hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE601
33342-409-10Dapagliflozin and Metformin Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE901
33342-409-15Dapagliflozin and Metformin Hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE5001
33342-409-66Dapagliflozin and Metformin Hydrochloride10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-409-07EA - Each33342-4094839cec7-f605-47be-8859-3d7fec47529a12026-05-22

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 5 of 161 · 3,205 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tox-ChordALFALFA, ALUMINA, BENZOICUM AC, CARBONEUM, CETRARIA, FOLLICULINUM, FUCUS, FUMARICUM AC, HEPAR SUIS, KALI CARB, KREOSOTUM, NAT MUR, PARAFFINUM, PETROLEUM, PHOSPHORICUM AC, PHOS, PIX LIQUIDA, PLANTAGO, PLUMB MET, PULSATILLA, RADIUM BROM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM, TABACUM, TEREBINTHINA, THYROIDINUM, TRITICUM, ZINC OXYD.Energetix Corporationb06b4794-e5bb-4ccd-87fd-37afca7b0f982026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Thyro-ChordHOMEOPATHIC LIQUIDEnergetix Corporation6655b504-dfa8-46df-9d3a-b7fa4078207e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Para-ChordHOMEOPATHIC LIQUIDEnergetix Corporation9f8f646e-634a-47ff-b208-b2249d685e552026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
MycoCan-ChordALUMINA, AVENA SATIVA, BORAX, CANDIDA ALBICANS, CARBOLICUM ACIDUM, CEANOTHUS AMERICANUS, ECHINACEA, GAULTHERIA PROCUMBENS, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, LINUM USITATISSIMUM, LITHIUM CARBONICUM, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SARCOLACTICUM ACIDUM, SEPIA, SILICEA, SOLIDAGO VIRGAUREA, TELLURIUM METALLICUM, TEUCRIUM MARUM, ZINCUM METALLICUMEnergetix Corporation227199f8-a45e-44ff-892d-ade4fefea3542026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLCd19c7ed0-ad5c-426e-b2df-722508f97d672026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Synjardy XREMPAGLIFLOZIN, METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.8006ba29-ee3a-f852-a9bb-c8ec9b41cf662026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
XIGDUO XRDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEAstraZeneca Pharmaceuticals LPac8a0f7b-9f69-4495-abbc-3a47cd75a8592026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1593072
rxcui: 1593068
rxcui: 1593058
rxcui: 1593070
unii: 786Z46389E
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEBryant Ranch Prepackc1bfc7b5-c7e0-4353-b772-05d463c128862026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
ROROBELL WAWA Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEROROBELL58336a0d-49dd-ef13-e063-6394a90a38c12026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.1e8136e0-cc98-41e4-ad4b-a8fc27fb4daa2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.4d087f00-580b-4b9d-80d9-f97930153e722026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.5d8d654a-9bb4-4c87-ab43-c21c4e8747082026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Metformin HydrochlorideMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.583f2a2e-a9d7-f266-e063-6294a90ad0ab2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 786Z46389E
Silicea 6XSILICON DIOXIDEHyland's Inc.db4be3c1-aa7e-24a2-e053-2a95a90a0c662026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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