FDA.reportPublic FDA data

Sitagliptin and Metformin hydrochloride

Product NDC
10370-351
11-digit product format
103700351
Labeler code
10370
Product ID
10370-351_6fd84734-1ea9-46b3-8ca9-0a61340f1390
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sitagliptin and metformin hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA204144
Marketing category
ANDA
Marketing start
2026-07-24
Substance
SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE
Active strength
100; 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204144-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-04
A204144-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-04
A204144-003SITAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204144-001AB
A204144-002AB
A204144-003AB

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 22:38:342026-08A204144-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-0484e616aacf4f…
2026-09-14 22:38:342026-08A204144-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-0484e616aacf4f…
2026-09-14 22:38:342026-08A204144-003SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-0484e616aacf4f…
2026-08-18 06:07:402026-07A204144-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-04caaa826d4ba7…
2026-08-18 06:07:402026-07A204144-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-04caaa826d4ba7…
2026-08-18 06:07:402026-07A204144-003SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204144-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORAL2025-06-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204144-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORAL2025-06-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204144-003SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORAL2025-06-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204144-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORAL2025-06-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204144-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORAL2025-06-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204144-003SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORAL2025-06-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A204144-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORAL2025-06-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204144-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORAL2025-06-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204144-003SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORAL2025-06-046a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204144-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-04a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204144-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-04a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204144-003SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-04a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A204144-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A204144-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A204144-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A204144-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204144-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204144-003AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204144-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204144-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204144-003AB1a50c72e98297…

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 PHOSPHATE100 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
43e3b1c9-3cbd-8dc3-e063-6394a90a10a2Available on FDA.report

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sitagliptin and Metformin hydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEPar Health USA, LLC43e3b1c9-3cbd-8dc3-e063-6394a90a10a22025-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204144
application number: ANDA204144
ndc (product): 10370-351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
10370-351-111037003511130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (10370-351-11) 2026-07-24NoNoCurrent