JANUMET

Product NDC
0006-0575
11-digit product format
000060575
Labeler code
0006
Product ID
0006-0575_601dfad8-02f7-4696-9fe2-548610338dc9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SITAGLIPTIN and METFORMIN HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Merck Sharp & Dohme LLC
Application
NDA022044
Marketing category
NDA
Marketing start
2007-03-30
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0006-05750006-0575-52DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N022044-001JANUMET500MG;EQ 50MG BASETABLET / ORALABRLD2007-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07N022044-002JANUMET1GM;EQ 50MG BASETABLET / ORALABRLD, RS2007-03-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022044-001JANUMET500MG;EQ 50MG BASETABLET / ORALABRLD2007-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022044-002JANUMET1GM;EQ 50MG BASETABLET / ORALABRLD, RS2007-03-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022044-001JANUMET500MG;EQ 50MG BASETABLET / ORALABRLD2007-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022044-002JANUMET1GM;EQ 50MG BASETABLET / ORALABRLD, RS2007-03-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N022044-001JANUMET500MG;EQ 50MG BASETABLET / ORALRLD2007-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022044-002JANUMET1GM;EQ 50MG BASETABLET / ORALRLD, RS2007-03-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022044-001JANUMET500MG;EQ 50MG BASETABLET / ORALRLD2007-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022044-002JANUMET1GM;EQ 50MG BASETABLET / ORALRLD, RS2007-03-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022044-001JANUMET500MG;EQ 50MG BASETABLET / ORALRLD2007-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022044-002JANUMET1GM;EQ 50MG BASETABLET / ORALRLD, RS2007-03-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022044-001JANUMET500MG;EQ 50MG BASETABLET / ORALRLD2007-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022044-002JANUMET1GM;EQ 50MG BASETABLET / ORALRLD, RS2007-03-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022044-001JANUMET500MG;EQ 50MG BASETABLET / ORALRLD2007-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022044-002JANUMET1GM;EQ 50MG BASETABLET / ORALRLD, RS2007-03-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022044-001JANUMET500MG;EQ 50MG BASETABLET / ORALRLD2007-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022044-002JANUMET1GM;EQ 50MG BASETABLET / ORALRLD, RS2007-03-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022044-001JANUMET500MG;EQ 50MG BASETABLET / ORALRLD2007-03-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022044-002JANUMET1GM;EQ 50MG BASETABLET / ORALRLD, RS2007-03-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022044-001JANUMET500MG;EQ 50MG BASETABLET / ORALRLD2007-03-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N022044-002JANUMET1GM;EQ 50MG BASETABLET / ORALRLD, RS2007-03-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022044-001JANUMET500MG;EQ 50MG BASETABLET / ORALRLD2007-03-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022044-002JANUMET1GM;EQ 50MG BASETABLET / ORALRLD, RS2007-03-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022044-001JANUMET500MG;EQ 50MG BASETABLET / ORALRLD2007-03-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022044-002JANUMET1GM;EQ 50MG BASETABLET / ORALRLD, RS2007-03-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022044-001JANUMET500MG;EQ 50MG BASETABLET / ORALRLD2007-03-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022044-002JANUMET1GM;EQ 50MG BASETABLET / ORALRLD, RS2007-03-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022044-001JANUMET500MG;EQ 50MG BASETABLET / ORALRLD2007-03-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022044-002JANUMET1GM;EQ 50MG BASETABLET / ORALRLD, RS2007-03-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022044-001JANUMET500MG;EQ 50MG BASETABLET / ORALRLD2007-03-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022044-002JANUMET1GM;EQ 50MG BASETABLET / ORALRLD, RS2007-03-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022044-001JANUMET500MG;EQ 50MG BASETABLET / ORALRLD2007-03-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022044-002JANUMET1GM;EQ 50MG BASETABLET / ORALRLD, RS2007-03-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022044-001JANUMET500MG;EQ 50MG BASETABLET / ORALRLD2007-03-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022044-002JANUMET1GM;EQ 50MG BASETABLET / ORALRLD, RS2007-03-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022044-001JANUMET500MG;EQ 50MG BASETABLET / ORALRLD2007-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022044-002JANUMET1GM;EQ 50MG BASETABLET / ORALRLD, RS2007-03-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022044-001JANUMET500MG;EQ 50MG BASETABLET / ORALRLD2007-03-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022044-002JANUMET1GM;EQ 50MG BASETABLET / ORALRLD, RS2007-03-30bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N022044-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N022044-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022044-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022044-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022044-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022044-002AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022044-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022044-002AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 14 · 560 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N022044-00173267082026-11-24U-802Drug substance, Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N022044-0017326708*PED2027-05-24Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N022044-00184149212028-07-21U-1036Drug product2013-04-09caaa826d4ba7…
2026-08-18 06:07:402026-07N022044-0018414921*PED2029-01-21Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N022044-00273267082026-11-24U-802Drug substance, Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N022044-0027326708*PED2027-05-24Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N022044-00284149212028-07-21U-1036Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N022044-0028414921*PED2029-01-21Pediatric extensioncaaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022044-00173267082026-11-24U-802Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022044-0017326708*PED2027-05-24Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022044-00184149212028-07-21U-1036Drug product2013-04-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022044-0018414921*PED2029-01-21Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022044-00273267082026-11-24U-802Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022044-0027326708*PED2027-05-24Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022044-00284149212028-07-21U-1036Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022044-0028414921*PED2029-01-21Pediatric extension011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022044-00173267082026-11-24U-802Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022044-0017326708*PED2027-05-24Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022044-00184149212028-07-21U-1036Drug product2013-04-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022044-0018414921*PED2029-01-21Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022044-00273267082026-11-24U-802Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022044-0027326708*PED2027-05-24Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022044-00284149212028-07-21U-1036Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022044-0028414921*PED2029-01-21Pediatric extension31067a03dcf5…
2025-08-23 18:47 UTC2025-08N022044-00173267082026-11-24U-802Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022044-0017326708*PED2027-05-24Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022044-00184149212028-07-21U-1036Drug product2013-04-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022044-0018414921*PED2029-01-21Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022044-00273267082026-11-24U-802Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022044-0027326708*PED2027-05-24Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022044-00284149212028-07-21U-1036Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022044-0028414921*PED2029-01-21Pediatric extension6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022044-00173267082026-11-24U-802Drug substance, Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022044-0017326708*PED2027-05-24Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022044-00184149212028-07-21U-1036Drug product2013-04-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022044-0018414921*PED2029-01-21Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022044-00273267082026-11-24U-802Drug substance, Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022044-0027326708*PED2027-05-24Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022044-00284149212028-07-21U-1036Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022044-0028414921*PED2029-01-21Pediatric extensionfd3edfee7708…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 180 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022044-001M-1872023-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022044-001PED2024-06-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022044-002M-1872023-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022044-002PED2024-06-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022044-001M-1872023-12-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022044-001PED2024-06-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022044-002M-1872023-12-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022044-002PED2024-06-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022044-001M-1872023-12-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022044-001PED2024-06-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022044-002M-1872023-12-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022044-002PED2024-06-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022044-001M-1872023-12-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022044-001PED2024-06-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022044-002M-1872023-12-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022044-002PED2024-06-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022044-001M-1872023-12-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N022044-001PED2024-06-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N022044-002M-1872023-12-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N022044-002PED2024-06-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022044-001M-1872023-12-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022044-001PED2024-06-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022044-002M-1872023-12-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022044-002PED2024-06-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022044-001M-1872023-12-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022044-001PED2024-06-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022044-002M-1872023-12-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022044-002PED2024-06-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022044-001M-1872023-12-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022044-001PED2024-06-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022044-002M-1872023-12-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022044-002PED2024-06-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022044-001M-1872023-12-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022044-001PED2024-06-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022044-002M-1872023-12-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022044-002PED2024-06-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022044-001M-2442022-08-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022044-001PED2023-02-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022044-001M-1872023-12-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022044-001PED2024-06-045c6f7cd8ea54…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SITAGLIPTIN PHOSPHATE500 mg/1
METFORMIN HYDROCHLORIDE50 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
861771Internal RxNorm lookup
861821Internal RxNorm lookup
2709488Internal RxNorm lookup
2709491Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d19c7ed0-ad5c-426e-b2df-722508f97d67Available 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
08b3e508-8c7e-3b95-0275-113510642fc6Product name220220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8Product name120200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86Product name120200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-0575-01JANUMET10 in 1 BLISTER PACKTABLET, FILM COATED1060
0006-0575-02JANUMET14 in 1 BOTTLETABLET, FILM COATED1460
0006-0575-03JANUMET2 in 1 CARTONTABLET, FILM COATED260
0006-0575-52JANUMET5 in 1 CARTONTABLET, FILM COATED560
0006-0575-56JANUMET4 in 1 CARTONTABLET, FILM COATED460
0006-0575-56JANUMET2 in 1 POUCHTABLET, FILM COATED260
0006-0575-61JANUMET60 in 1 BOTTLETABLET, FILM COATED6060
0006-0575-62JANUMET180 in 1 BOTTLETABLET, FILM COATED18060
0006-0575-82JANUMET1000 in 1 BOTTLETABLET, FILM COATED100060

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-0575-03EA - Each0006-0575a2ffd725-a6f5-4ce9-a833-6ef93830770012018-04-19
0006-0575-52EA - Each0006-0575148c6394-4724-465d-92de-e1498cebe5d612012-07-24
0006-0575-61EA - Each0006-05759615799d-ea7d-4fdc-b6eb-4353ab4b33cd12012-07-24
0006-0575-62EA - Each0006-057556c54b0f-7c1c-4a66-9565-2211f98cc53a12012-07-24
0006-0575-82EA - Each0006-0575ebb3d102-c8bd-48ce-bd56-db57f9570b0512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EJANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
SITAGLIPTIN PHOSPHATEACTIVE INGREDIENTTS63EW8X6FJANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
METFORMINACTIVE MOIETY9100L32L2NJANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
SITAGLIPTINACTIVE MOIETYQFP0P1DV7ZJANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UJANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AJANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQJANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JJANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIJANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
TALCINACTIVE INGREDIENT7SEV7J4R1UJANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPJANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-0575JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME LLC]60Current NDC, Legacy NDC, 9 package rows20250331_d19c7ed0-ad5c-426e-b2df-722508f97d67.zip

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 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
ndc (product): 0006-0575

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861771Janumet 50 MG / 1000 MG Oral TabletPSNd19c7ed0-ad5c-426e-b2df-722508f97d6760
861821Janumet 50 MG / 500 MG Oral TabletPSNd19c7ed0-ad5c-426e-b2df-722508f97d6760
2709488metFORMIN hydrochloride 1000 MG / SITagliptin phosphate 50 MG Oral TabletPSNd19c7ed0-ad5c-426e-b2df-722508f97d6760
2709491metFORMIN hydrochloride 500 MG / SITagliptin phosphate 50 MG Oral TabletPSNd19c7ed0-ad5c-426e-b2df-722508f97d6760
861771metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG Oral Tablet [Janumet]SBDd19c7ed0-ad5c-426e-b2df-722508f97d6760
861821metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG Oral Tablet [Janumet]SBDd19c7ed0-ad5c-426e-b2df-722508f97d6760
2709488metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG Oral TabletSCDd19c7ed0-ad5c-426e-b2df-722508f97d6760
2709491metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG Oral TabletSCDd19c7ed0-ad5c-426e-b2df-722508f97d6760
861771Janumet 50 mg/1000 mg Oral TabletSYd19c7ed0-ad5c-426e-b2df-722508f97d6760
861821Janumet 50 mg/500 mg Oral TabletSYd19c7ed0-ad5c-426e-b2df-722508f97d6760
861771Janumet 50/1000 (sitagliptin phosphate 64.25 MG / metformin hydrochloride) Oral TabletSYd19c7ed0-ad5c-426e-b2df-722508f97d6760
861821Janumet 50/500 (sitagliptin phosphate 64.25 MG / metformin hydrochloride) Oral TabletSYd19c7ed0-ad5c-426e-b2df-722508f97d6760
861821Janumet 50 MG / 500 MG Oral TabletPSNb55ee3d9-7f0b-4dd9-9213-fbc69f09f56711
2709491metFORMIN hydrochloride 500 MG / SITagliptin phosphate 50 MG Oral TabletPSNb55ee3d9-7f0b-4dd9-9213-fbc69f09f56711
861821metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG Oral Tablet [Janumet]SBDb55ee3d9-7f0b-4dd9-9213-fbc69f09f56711
2709491metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG Oral TabletSCDb55ee3d9-7f0b-4dd9-9213-fbc69f09f56711
861821Janumet 50 mg/500 mg Oral TabletSYb55ee3d9-7f0b-4dd9-9213-fbc69f09f56711
861821Janumet 50/500 (sitagliptin phosphate 64.25 MG / metformin hydrochloride) Oral TabletSYb55ee3d9-7f0b-4dd9-9213-fbc69f09f56711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-0575-010000605750110 in 1 BLISTER PACKHistorical
0006-0575-020000605750214 in 1 BOTTLEHistorical
0006-0575-03000060575032 BOTTLE in 1 CARTON (0006-0575-03) / 14 TABLET, FILM COATED in 1 BOTTLE (0006-0575-02) 2 bottle2007-03-300000-00-00YesNoCurrent
0006-0575-52000060575525 in 1 CARTONHistorical
0006-0575-56000060575564 POUCH in 1 CARTON (0006-0575-56) / 2 BLISTER PACK in 1 POUCH / 7 TABLET, FILM COATED in 1 BLISTER PACK4 pouch2007-03-300000-00-00YesNoCurrent
0006-0575-610000605756160 TABLET, FILM COATED in 1 BOTTLE (0006-0575-61) 2007-03-300000-00-00NoNoCurrent
0006-0575-6200006057562180 TABLET, FILM COATED in 1 BOTTLE (0006-0575-62) 2007-03-300000-00-00NoNoCurrent
0006-0575-82000060575821000 TABLET, FILM COATED in 1 BOTTLE (0006-0575-82) 2007-03-300000-00-00NoNoCurrent