FDA.reportPublic FDA data

dapagliflozin

Product NDC
33342-585
11-digit product format
333420585
Labeler code
33342
Product ID
33342-585_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
5 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 · 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
2026-08-01 22:54:322026-06A211506-001DAPAGLIFLOZIN5MGTABLET / ORALAB2026-04-06a50c72e98297…
2026-08-01 22:54:322026-06A211506-002DAPAGLIFLOZIN10MGTABLET / ORALAB2026-04-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211506-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A211506-002AB1a50c72e98297…

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
dapagliflozinDAPAGLIFLOZINMacleods Pharmaceuticals Limited91373924-66dc-4277-aaf2-8536e81a0e4d2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211506
application number: ANDA211506
ndc (product): 33342-585

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPAGLIFLOZIN5 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
33342-585-07dapagliflozin30 in 1 BOTTLETABLET302
33342-585-10dapagliflozin90 in 1 BOTTLETABLET902
33342-585-12dapagliflozin10 in 1 CARTONTABLET102
33342-585-66dapagliflozin10 in 1 BLISTER PACKTABLET102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-585-07EA - Each33342-5851da58a81-1171-4ec5-a565-6094282593c912026-05-22
33342-585-10EA - Each33342-58551e730e9-cf27-482d-b312-3705fdcc843312026-05-22

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
33342-585-073334205850730 TABLET in 1 BOTTLE (33342-585-07) 30 tablet2026-04-06NoNoCurrent
33342-585-103334205851090 TABLET in 1 BOTTLE (33342-585-10) 90 tablet2026-04-06NoNoCurrent
33342-585-123334205851210 BLISTER PACK in 1 CARTON (33342-585-12) / 10 TABLET in 1 BLISTER PACK (33342-585-66) 10 blister pack2026-04-06NoNoCurrent
33342-585-663334205856610 in 1 BLISTER PACKHistorical