FDA.reportPublic FDA data

Sitagliptin and Metformin Hydrochloride

Product NDC
60505-3659
11-digit product format
605053659
Labeler code
60505
Product ID
60505-3659_15cfffcf-3241-3e53-1f1e-ad300900662e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sitagliptin and Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA202426
Marketing category
ANDA
Marketing start
2026-05-28
Substance
SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE
Active strength
50; 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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A202426-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE500MG;EQ 50MG BASETABLET / ORALAB2026-04-30
A202426-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE1GM;EQ 50MG BASETABLET / ORALAB2026-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202426-001AB
A202426-002AB

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
2026-09-14 22:38:342026-08A202426-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET / ORALAB2026-04-3084e616aacf4f…
2026-09-14 22:38:342026-08A202426-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET / ORALAB2026-04-3084e616aacf4f…
2026-08-18 06:07:402026-07A202426-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET / ORALAB2026-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07A202426-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET / ORALAB2026-04-30caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202426-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET / ORALAB2026-04-30a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202426-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET / ORALAB2026-04-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A202426-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A202426-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A202426-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202426-002AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202426-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202426-002AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Sitagliptin and Metformin Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SITAGLIPTIN PHOSPHATE50 mg/1
METFORMIN HYDROCHLORIDE1000 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
950613e2-e959-6b57-e172-251ddc53c64cAvailable 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
60505-3659-6Sitagliptin and Metformin Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
60505-3659-7Sitagliptin and Metformin Hydrochloride180 in 1 BOTTLETABLET, FILM COATED1801

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sitagliptin and Metformin HydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEGolden State Medical Supply, Inc.58f0e875-5d9b-be0b-e063-6394a90a53452026-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202426
application number: ANDA202426
Sitagliptin and Metformin HydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEApotex Corp.950613e2-e959-6b57-e172-251ddc53c64c2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202426
application number: ANDA202426
ndc (product): 60505-3659

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2709488metFORMIN hydrochloride 1000 MG / SITagliptin phosphate 50 MG Oral TabletPSN950613e2-e959-6b57-e172-251ddc53c64c1
2709491metFORMIN hydrochloride 500 MG / SITagliptin phosphate 50 MG Oral TabletPSN950613e2-e959-6b57-e172-251ddc53c64c1
2709488metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG Oral TabletSCD950613e2-e959-6b57-e172-251ddc53c64c1
2709491metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG Oral TabletSCD950613e2-e959-6b57-e172-251ddc53c64c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60505-3659-66050536590660 TABLET, FILM COATED in 1 BOTTLE (60505-3659-6) 2026-05-28NoNoCurrent
60505-3659-760505365907180 TABLET, FILM COATED in 1 BOTTLE (60505-3659-7) 2026-05-28NoNoCurrent