FDA.reportPublic FDA data

JANUMET

Product NDC
0006-0081
11-digit product format
000060081
Labeler code
0006
Product ID
0006-0081_4323fb1c-54a7-4648-bfe0-28fb4cb65f50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sitagliptin and metformin hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Merck Sharp & Dohme LLC
Application
NDA202270
Marketing category
NDA
Marketing start
2012-02-02
Substance
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Active strength
1000; 100 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
2026-12-31
Current FDA listing
Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N202270-001JANUMET XRMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALABRLD2012-02-02
N202270-002JANUMET XRMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALABRLD2012-02-02
N202270-003JANUMET XRMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2012-02-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N202270-001AB
N202270-002AB
N202270-003AB

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N202270-00173267082026-11-24U-1227Drug substance, Drug product
N202270-0017326708*PED2027-05-24Pediatric extension
N202270-00273267082026-11-24U-1227Drug substance, Drug product
N202270-0027326708*PED2027-05-24Pediatric extension
N202270-00373267082026-11-24U-1227Drug substance, Drug product
N202270-0037326708*PED2027-05-24Pediatric 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 22:54:322026-06N202270-001JANUMET XR500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALABRLD2012-02-02a50c72e98297…
2026-08-01 22:54:322026-06N202270-002JANUMET XR1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALABRLD2012-02-02a50c72e98297…
2026-08-01 22:54:322026-06N202270-003JANUMET XR1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2012-02-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N202270-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N202270-002AB1a50c72e98297…
2026-08-01 22:54:322026-06N202270-003AB1a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N202270-00173267082026-11-24U-1227Drug substance, Drug producta50c72e98297…
2026-08-01 22:54:322026-06N202270-0017326708*PED2027-05-24Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N202270-00273267082026-11-24U-1227Drug substance, Drug producta50c72e98297…
2026-08-01 22:54:322026-06N202270-0027326708*PED2027-05-24Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N202270-00373267082026-11-24U-1227Drug substance, Drug producta50c72e98297…
2026-08-01 22:54:322026-06N202270-0037326708*PED2027-05-24Pediatric 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JANUMET XRSITAGLIPTIN AND METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLC64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b502025-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 202270
application number: NDA202270
ndc (product): 0006-0081
JANUMET XRSITAGLIPTIN AND METFORMIN HYDROCHLORIDEA-S Medication Solutions90c0244b-afb3-4e69-b79f-486d002ca4322023-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 202270
application number: NDA202270

Additional Listing Data#

Finished product
Yes
Brand name base
JANUMET
Brand name suffix
XR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SITAGLIPTIN PHOSPHATE1000 mg/1
METFORMIN HYDROCHLORIDE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TS63EW8X6FInternal UNII lookup
786Z46389EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1243833Internal RxNorm lookup
1243843Internal RxNorm lookup
1243848Internal RxNorm lookup
2709470Internal RxNorm lookup
2709477Internal RxNorm lookup
2709482Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a29d87d-f465-752d-5fa9-bd728c608ca2Product name420251215
19a549d9-1cb9-4833-ba02-91db3dcb07baProduct name120251107
f6d21fb1-2c09-48ab-8d89-eeadf5a9698eProduct name120250724
ff2e6e82-af62-4b84-b1ca-09520f6c5a79Product name120250630
a985afd1-89a8-bfab-0231-b59db1a3a9b5Product name720250515
25bfaa4d-02a1-402c-96ec-9bf6e625484cProduct name120250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0Product name220240829
16dbe107-66d5-47b3-57ed-0cba6a8dfcccProduct name620240215
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
08b3e508-8c7e-3b95-0275-113510642fc6Product name220220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8Product name120200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86Product name120200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
ca3f036c-6c06-b829-b379-1a3a4097099cProduct name920180605
e1ede89f-54c8-428f-ae84-9e8a2deb67dbProduct name120180306
fd232072-39c4-4416-9b66-265d18a7bd93Product name120180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52cProduct name220170824
bea938a6-c880-985b-d27b-b59b0d8b5a77Product name320170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2fProduct name120170616
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e2382c7e-9e14-4196-aeff-98e2cfaf63cbProduct name120170224
988f737f-e7e9-4613-8558-824b1ab755f9Product name120161128
58b66776-50d5-434f-916f-958ccf131e0eProduct name120160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
2988466d-5fc4-4430-9cee-fc9132f02d2cProduct name120150910
85cbb42f-1a8d-f945-f85e-188e823b7f5bProduct name220150731
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
e740bf83-275a-4f0c-adf4-ec60ebd882b7Product name120150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0Product name120141205
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6Product name120140508
2de6e143-c970-2061-1b77-61c3aa8f4026Product name120140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508
9fa860f8-41a8-caa8-93ae-a5bdc7b15db7Product name120140508
ce63c1f8-ba50-8a17-9290-94522d75daffProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-0081-07JANUMET XR7 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE743
0006-0081-14JANUMET XR2 in 1 CARTONTABLET, FILM COATED, EXTENDED RE243
0006-0081-31JANUMET XR30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3043
0006-0081-54JANUMET XR90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE9043
0006-0081-82JANUMET XR1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE100043

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-0081-14EA - Each0006-0081af302a7a-7646-40ed-a436-170db1bd792612018-04-19
0006-0081-31EA - Each0006-0081066f87e6-12cb-42b4-b845-91b25cb6fec812012-07-24
0006-0081-54EA - Each0006-00817d860f87-9fb8-44ae-9093-da0fe5b30d6a12012-07-24
0006-0081-82EA - Each0006-00811389872e-160a-4daa-8a15-87202729539712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EJANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]16
SITAGLIPTIN PHOSPHATEACTIVE INGREDIENTTS63EW8X6FJANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]16
METFORMINACTIVE MOIETY9100L32L2NJANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]16
SITAGLIPTINACTIVE MOIETYQFP0P1DV7ZJANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]16
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]16
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZJANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UJANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]16
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKJANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]16
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTJANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]16
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PJANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]16
HYPROMELLOSE 2208 (100000 MPA.S)INACTIVE INGREDIENTVM7F0B23ZIJANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]16
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]16
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LJANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]16
KAOLININACTIVE INGREDIENT24H4NWX5COJANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]16
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PJANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]16
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQJANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]16
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]16
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIJANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPJANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-0081JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME LLC]43Current NDC, Legacy NDC, 5 package rows20250331_64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243833Janumet XR 100 MG / 1000 MG 24HR Extended Release Oral TabletPSN64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
1243843Janumet XR 50 MG / 1000 MG 24HR Extended Release Oral TabletPSN64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
1243848Janumet XR 50 MG / 500 MG 24HR Extended Release Oral TabletPSN64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
2709470metFORMIN hydrochloride 1000 MG / SITagliptin phosphate 100 MG 24HR Extended Release Oral TabletPSN64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
2709477metFORMIN hydrochloride 1000 MG / SITagliptin phosphate 50 MG 24HR Extended Release Oral TabletPSN64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
2709482metFORMIN hydrochloride 500 MG / SITagliptin phosphate 50 MG 24HR Extended Release Oral TabletPSN64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
124383324 HR metformin hydrochloride 1000 MG / sitagliptin phosphate 100 MG Extended Release Oral Tablet [Janumet]SBD64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
124384324 HR metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG Extended Release Oral Tablet [Janumet]SBD64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
124384824 HR metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG Extended Release Oral Tablet [Janumet]SBD64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
270947024 HR metformin hydrochloride 1000 MG / sitagliptin phosphate 100 MG Extended Release Oral TabletSCD64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
270947724 HR metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG Extended Release Oral TabletSCD64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
270948224 HR metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG Extended Release Oral TabletSCD64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
1243833Janumet XR 100/1000 (sitagliptin (sitagliptin phosphate monohydrate 128.5 MG) / metformin hydrochloride) 24 HR Extended Release Oral TabletSY64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
1243833Janumet XR 100/1000 (sitagliptin / metformin hydrochloride) 24 HR Extended Release Oral TabletSY64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
1243833Janumet XR 100/1000 24 HR Extended Release Oral TabletSY64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
1243843Janumet XR 50/1000 (sitagliptin (sitagliptin phosphate monohydrate 64.25 MG) / metformin hydrochloride) 24 HR Extended Release Oral TabletSY64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
1243843Janumet XR 50/1000 (sitagliptin / metformin hydrochloride) 24 HR Extended Release Oral TabletSY64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
1243843Janumet XR 50/1000 24 HR Extended Release Oral TabletSY64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
1243848Janumet XR 50/500 (sitagliptin (sitagliptin phosphate monohydrate 64.25 MG) / metformin hydrochloride) 24 HR Extended Release Oral TabletSY64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
1243848Janumet XR 50/500 (sitagliptin / metformin hydrochloride) 24 HR Extended Release Oral TabletSY64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
1243848Janumet XR 50/500 24 HR Extended Release Oral TabletSY64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
2709470metformin hydrochloride 1000 MG / sitagliptin phosphate 100 MG 24 HR Extended Release Oral TabletSY64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
2709477metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG 24 HR Extended Release Oral TabletSY64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043
2709482metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG 24 HR Extended Release Oral TabletSY64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b5043

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-0081-07000060081077 in 1 BOTTLEHistorical
0006-0081-14000060081142 BOTTLE in 1 CARTON (0006-0081-14) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0081-07) 2 bottle2012-02-020000-00-00YesNoCurrent
0006-0081-310000600813130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0081-31) 2012-02-020000-00-00NoNoCurrent
0006-0081-540000600815490 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0081-54) 2012-02-020000-00-00NoNoCurrent
0006-0081-82000060081821000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0081-82) 2012-02-020000-00-00NoNoCurrent