FDA.reportPublic FDA data

JANUMET

Product NDC
0006-0078
11-digit product format
000060078
Labeler code
0006
Product ID
0006-0078_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
500; 50 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

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
METFORMIN HYDROCHLORIDE500 mg/1
SITAGLIPTIN PHOSPHATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTS63EW8X6F, 786Z46389E
Rxcui1243833, 1243843, 1243848, 2709470, 2709477, 2709482

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
0006-0078-14JANUMET XR14 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1443
0006-0078-28JANUMET XR2 in 1 CARTONTABLET, FILM COATED, EXTENDED RE243
0006-0078-61JANUMET XR60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6043
0006-0078-62JANUMET XR180 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE18043
0006-0078-82JANUMET 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
0006-0078-61EA - Each0006-00788df8f293-3f4e-418f-89cd-64408a56622d12012-07-24
0006-0078-62EA - Each0006-0078894309b7-197b-4207-8fb7-a35a1e72d06912012-07-24
0006-0078-82EA - Each0006-007891ab02c4-542d-4436-bbc7-9ec068bb5f3312012-07-24

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
0006-0078JANUMET 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
0006-0078-140000600781414 in 1 BOTTLEHistorical
0006-0078-28000060078282 BOTTLE in 1 CARTON (0006-0078-28) / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-14) 2 bottle2012-02-020000-00-00YesNoCurrent
0006-0078-610000600786160 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-61) 2012-02-020000-00-00NoNoCurrent
0006-0078-6200006007862180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-62) 2012-02-020000-00-00NoNoCurrent
0006-0078-82000060078821000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-82) 2012-02-020000-00-00NoNoCurrent