FDA.reportPublic FDA data

dapagliflozin

Product NDC
33342-586
Requested package NDC
33342-586-56
11-digit product format
333420586
Labeler code
33342
Product ID
33342-586_4fa5c1b8-9912-4fb8-a3b9-c105fbf641a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dapagliflozin
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA211506
Marketing category
ANDA
Marketing start
2026-04-06
Substance
DAPAGLIFLOZIN
Active strength
10 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 42.

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
A211506-001DAPAGLIFLOZINDAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-06
A211506-002DAPAGLIFLOZINDAPAGLIFLOZIN10MGTABLET / ORALAB2026-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211506-001AB
A211506-002AB

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
2026-08-18 06:07:402026-07A211506-001DAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A211506-002DAPAGLIFLOZIN10MGTABLET / ORALAB2026-04-06caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211506-001DAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211506-002DAPAGLIFLOZIN10MGTABLET / ORALAB2026-04-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A211506-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211506-002AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211506-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211506-002AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPAGLIFLOZIN10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1488569Internal RxNorm lookup
1488574Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
91373924-66dc-4277-aaf2-8536e81a0e4dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
33342-586-07dapagliflozin30 in 1 BOTTLETABLET302
33342-586-10dapagliflozin90 in 1 BOTTLETABLET902
33342-586-56dapagliflozin10 in 1 CARTONTABLET102
33342-586-66dapagliflozin14 in 1 BLISTER PACKTABLET142

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-586-07EA - Each33342-58606133bb6-03ff-43d8-8f7e-3d7712382fd512026-05-22
33342-586-10EA - Each33342-586669bd915-dd40-4830-8939-c62ee12bc3f112026-05-22

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
dapagliflozinDAPAGLIFLOZINMacleods Pharmaceuticals Limited91373924-66dc-4277-aaf2-8536e81a0e4d2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211506
application number: ANDA211506
ndc (package): 33342-586-56
ndc (product): 33342-586
ndc11 (package): 33342058656

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1488569dapagliflozin 10 MG Oral TabletPSN91373924-66dc-4277-aaf2-8536e81a0e4d2
1488574dapagliflozin 5 MG Oral TabletPSN91373924-66dc-4277-aaf2-8536e81a0e4d2
1488569dapagliflozin 10 MG Oral TabletSCD91373924-66dc-4277-aaf2-8536e81a0e4d2
1488574dapagliflozin 5 MG Oral TabletSCD91373924-66dc-4277-aaf2-8536e81a0e4d2
1488569dapagliflozin 10 MG Oral TabletSY91373924-66dc-4277-aaf2-8536e81a0e4d2
1488574dapagliflozin 5 MG Oral TabletSY91373924-66dc-4277-aaf2-8536e81a0e4d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-586-563334205865610 BLISTER PACK in 1 CARTON (33342-586-56) / 14 TABLET in 1 BLISTER PACK (33342-586-66) 10 blister pack2026-04-06NoNoCurrent