FDA.reportPublic FDA data

KOMBIGLYZE

Product NDC
0310-6125
Requested package NDC
0310-6125-92
11-digit product format
003106125
Labeler code
0310
Product ID
0310-6125_f2b2e5cb-8544-4aae-a3b6-96c8517dab61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA200678
Marketing category
NDA
Marketing start
2014-12-04
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Active strength
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0310-61250310-6125-92DDiscontinued by firm2026-07-31

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
N200678-001KOMBIGLYZE XRMETFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2010-11-05
N200678-002KOMBIGLYZE XRMETFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2010-11-05
N200678-003KOMBIGLYZE XRMETFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2010-11-05

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N200678-001M-142027-10-11
N200678-002M-142027-10-11
N200678-003M-142027-10-11

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 22:54:322026-06N200678-001KOMBIGLYZE XR500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2010-11-05a50c72e98297…
2026-08-01 22:54:322026-06N200678-002KOMBIGLYZE XR1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2010-11-05a50c72e98297…
2026-08-01 22:54:322026-06N200678-003KOMBIGLYZE XR1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2010-11-05a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N200678-001M-142027-10-11a50c72e98297…
2026-08-01 22:54:322026-06N200678-002M-142027-10-11a50c72e98297…
2026-08-01 22:54:322026-06N200678-003M-142027-10-11a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-6125-60EA - Each0310-61251c4fa4e6-e1d3-495a-90b0-ab43e68c9e9112015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
metformin hydrochlorideACTIVE INGREDIENT786Z46389EKOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]3
saxagliptin hydrochlorideACTIVE INGREDIENTZ8J84YIX6LKOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]3
metforminACTIVE MOIETY9100L32L2NKOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]3
saxagliptin anhydrousACTIVE MOIETY8I7IO46IVQKOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]3
hypromellose 2208 (15000 mpa.s)INACTIVE INGREDIENTZ78RG6M2N2KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]3
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WKOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]3
magnesium stearateINACTIVE INGREDIENT70097M6I30KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-6125KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]23Legacy NDC20241020_fbd25da4-ebe6-45c9-beb8-93523d11a0b4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0310-6125-92003106125921 BLISTER PACK in 1 CARTON (0310-6125-92) > 12 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2014-12-042023-02-28YesNoCurrent