FDA.reportPublic FDA data

DAPAGLIFLOZIN AND SAXAGLIPTIN

Product NDC
72205-438
11-digit product format
722050438
Labeler code
72205
Product ID
72205-438_1cfa51fd-8406-404c-b2a8-0fc1068675fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DAPAGLIFLOZIN AND SAXAGLIPTIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA211533
Marketing category
ANDA
Marketing start
2026-04-06
Substance
DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE
Active strength
10; 5 mg/1; mg/1
Pharmacologic classes
Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211533-001DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDEDAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE10MG;EQ 5MG BASETABLET / ORALABRS2026-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211533-001AB

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
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211533-001DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE10MG;EQ 5MG BASETABLET / ORALABRS2026-04-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211533-001AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPAGLIFLOZIN10 mg/1
SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1ULL0QJ8UCInternal UNII lookup
4N19ON48ZNInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1925498Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1cfa51fd-8406-404c-b2a8-0fc1068675fbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0Product name220240829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c30aab5e-c89f-4b59-83b1-99a940b63351Product name120200925
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
85b4e38c-4488-4e48-919e-244e107d9bd9Product name220190731
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52cProduct name220170824

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-438-01DAPAGLIFLOZIN AND SAXAGLIPTIN30 in 1 BOTTLETABLET, FILM COATED301
72205-438-02DAPAGLIFLOZIN AND SAXAGLIPTIN90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-438-01EA - Each72205-438d8eb614b-6d26-4728-8527-8e01f2c245ad12026-05-22

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
DAPAGLIFLOZIN AND SAXAGLIPTINDAPAGLIFLOZIN AND SAXAGLIPTINNovadoz Pharmaceuticals LLC1cfa51fd-8406-404c-b2a8-0fc1068675fb2026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211533
application number: ANDA211533
ndc (product): 72205-438

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1925498dapagliflozin 10 MG / sAXagliptin 5 MG Oral TabletPSN1cfa51fd-8406-404c-b2a8-0fc1068675fb1
1925498dapagliflozin 10 MG / saxagliptin 5 MG Oral TabletSCD1cfa51fd-8406-404c-b2a8-0fc1068675fb1
1925498dapagliflozin 10 MG (as dapagliflozin propanediol 12.3 MG) / saxagliptin 5 MG (as saxagliptin HCl 5.95 MG) Oral TabletSY1cfa51fd-8406-404c-b2a8-0fc1068675fb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72205-438-017220504380130 TABLET, FILM COATED in 1 BOTTLE (72205-438-01) 2026-04-09NoNoCurrent
72205-438-027220504380290 TABLET, FILM COATED in 1 BOTTLE (72205-438-02) 2026-04-09NoNoCurrent