FDA.reportPublic FDA data

SAXAGLIPTIN

Product NDC
68462-727
11-digit product format
684620727
Labeler code
68462
Product ID
68462-727_4d1a25c6-4ffc-4714-98a9-c4dcb2049d6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SAXAGLIPTIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA205994
Marketing category
ANDA
Marketing start
2023-07-31
Substance
SAXAGLIPTIN HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
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 1.

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
A205994-001SAXAGLIPTINSAXAGLIPTIN HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2023-07-31
A205994-002SAXAGLIPTINSAXAGLIPTIN HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2023-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205994-001AB
A205994-002AB

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
2026-08-01 22:54:322026-06A205994-001SAXAGLIPTINEQ 2.5MG BASETABLET / ORALAB2023-07-31a50c72e98297…
2026-08-01 22:54:322026-06A205994-002SAXAGLIPTINEQ 5MG BASETABLET / ORALAB2023-07-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205994-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A205994-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SAXAGLIPTINSAXAGLIPTINGlenmark Pharmaceuticals Inc., USAe286ffd4-c598-47fb-af06-2e15f7e6f99f2026-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205994
application number: ANDA205994
ndc (product): 68462-727

Additional Listing Data#

Finished product
Yes
Brand name base
SAXAGLIPTIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SAXAGLIPTIN HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Z8J84YIX6LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
858036Internal RxNorm lookup
858042Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e286ffd4-c598-47fb-af06-2e15f7e6f99fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0Product name220240829
f5a91c01-b85a-4a74-4259-0bddd9950e83Product name220240828
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
85b4e38c-4488-4e48-919e-244e107d9bd9Product name220190731

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-727-05SAXAGLIPTIN500 in 1 BOTTLETABLET, FILM COATED5002
68462-727-14SAXAGLIPTIN10 in 1 CARTONTABLET, FILM COATED102
68462-727-14SAXAGLIPTIN10 in 1 BLISTER PACKTABLET, FILM COATED102
68462-727-30SAXAGLIPTIN30 in 1 BOTTLETABLET, FILM COATED302
68462-727-90SAXAGLIPTIN90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-727-30EA - Each68462-727074a97df-2a6a-4938-9c33-11e6ac19acbf12023-09-05
68462-727-90EA - Each68462-72709171a9a-fcbc-417b-b572-35acff612d9912023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-727SAXAGLIPTIN TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]1Current NDC, 5 package rows20230808_e286ffd4-c598-47fb-af06-2e15f7e6f99f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858042sAXagliptin 2.5 MG Oral TabletPSNe286ffd4-c598-47fb-af06-2e15f7e6f99f2
858036sAXagliptin 5 MG Oral TabletPSNe286ffd4-c598-47fb-af06-2e15f7e6f99f2
858042saxagliptin 2.5 MG Oral TabletSCDe286ffd4-c598-47fb-af06-2e15f7e6f99f2
858036saxagliptin 5 MG Oral TabletSCDe286ffd4-c598-47fb-af06-2e15f7e6f99f2
858042saxagliptin 2.5 MG (as saxagliptin HCl, anhydrous 2.79 MG) Oral TabletSYe286ffd4-c598-47fb-af06-2e15f7e6f99f2
858036saxagliptin 5 MG (as saxagliptin HCl, anhydrous 5.58 MG) Oral TabletSYe286ffd4-c598-47fb-af06-2e15f7e6f99f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68462-727-0568462072705500 TABLET, FILM COATED in 1 BOTTLE (68462-727-05) 2023-07-31NoNoCurrent
68462-727-146846207271410 BLISTER PACK in 1 CARTON (68462-727-14) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2023-07-31NoNoCurrent
68462-727-306846207273030 TABLET, FILM COATED in 1 BOTTLE (68462-727-30) 2023-07-31NoNoCurrent
68462-727-906846207279090 TABLET, FILM COATED in 1 BOTTLE (68462-727-90) 2023-07-31NoNoCurrent