FDA.reportPublic FDA data

JANUMET

Product NDC
70518-2548
11-digit product format
705182548
Labeler code
70518
Product ID
70518-2548_dc2622ce-d51f-36ef-e053-2995a90a343e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SITAGLIPTIN and METFORMIN HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA022044
Marketing category
NDA
Marketing start
2020-01-20
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Active strength
1000 mg/1; mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-2548DDiscontinued by firm2026-07-31
excluded packagepackage70518-254870518-2548-0DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022044-001JANUMETMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE500MG;EQ 50MG BASETABLET / ORALABRLD2007-03-30
N022044-002JANUMETMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE1GM;EQ 50MG BASETABLET / ORALABRLD, RS2007-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N022044-001AB
N022044-002AB

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022044-00173267082026-11-24U-802Drug substance, Drug product
N022044-0017326708*PED2027-05-24Pediatric extension
N022044-00184149212028-07-21U-1036Drug product2013-04-09
N022044-0018414921*PED2029-01-21Pediatric extension
N022044-00273267082026-11-24U-802Drug substance, Drug product
N022044-0027326708*PED2027-05-24Pediatric extension
N022044-00284149212028-07-21U-1036Drug product
N022044-0028414921*PED2029-01-21Pediatric extension

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N022044-001JANUMET500MG;EQ 50MG BASETABLET / ORALABRLD2007-03-30a50c72e98297…
2026-08-01 22:54:322026-06N022044-002JANUMET1GM;EQ 50MG BASETABLET / ORALABRLD, RS2007-03-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N022044-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N022044-002AB1a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N022044-00173267082026-11-24U-802Drug substance, Drug producta50c72e98297…
2026-08-01 22:54:322026-06N022044-0017326708*PED2027-05-24Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022044-00184149212028-07-21U-1036Drug product2013-04-09a50c72e98297…
2026-08-01 22:54:322026-06N022044-0018414921*PED2029-01-21Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022044-00273267082026-11-24U-802Drug substance, Drug producta50c72e98297…
2026-08-01 22:54:322026-06N022044-0027326708*PED2027-05-24Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022044-00284149212028-07-21U-1036Drug producta50c72e98297…
2026-08-01 22:54:322026-06N022044-0028414921*PED2029-01-21Pediatric extensiona50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEA-S Medication Solutionsc603b844-2019-4ef4-8385-7bc3f96a25652026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022044
application number: NDA022044
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEA-S Medication Solutionsb55ee3d9-7f0b-4dd9-9213-fbc69f09f5672026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022044
application number: NDA022044
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLCd19c7ed0-ad5c-426e-b2df-722508f97d672025-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022044
application number: NDA022044

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2548-07051825480090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2548-0) 2020-01-200000-00-00NoNoCurrent