FDA.reportPublic FDA data

DASATINIB

Product NDC
59651-547
11-digit product format
596510547
Labeler code
59651
Product ID
59651-547_58ce42c6-10bd-4bb4-bf89-eae8ed82c339
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DASATINIB
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA216547
Marketing category
ANDA
Marketing start
2025-04-22
Substance
DASATINIB
Active strength
140 mg/1
Pharmacologic classes
Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216547-001DASATINIBDASATINIB20MGTABLET / ORALAB2025-04-22
A216547-002DASATINIBDASATINIB50MGTABLET / ORALAB2025-04-22
A216547-003DASATINIBDASATINIB70MGTABLET / ORALAB2025-04-22
A216547-004DASATINIBDASATINIB80MGTABLET / ORALAB2025-04-22
A216547-005DASATINIBDASATINIB100MGTABLET / ORALAB2025-04-22
A216547-006DASATINIBDASATINIB140MGTABLET / ORALAB2025-04-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A216547-001AB
A216547-002AB
A216547-003AB
A216547-004AB
A216547-005AB
A216547-006AB

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
2026-02-19 14:30 UTC2026-02A216547-001DASATINIB20MGTABLET / ORALAB2025-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216547-002DASATINIB50MGTABLET / ORALAB2025-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216547-003DASATINIB70MGTABLET / ORALAB2025-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216547-004DASATINIB80MGTABLET / ORALAB2025-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216547-005DASATINIB100MGTABLET / ORALAB2025-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216547-006DASATINIB140MGTABLET / ORALAB2025-04-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216547-001DASATINIB20MGTABLET / ORALAB2025-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216547-002DASATINIB50MGTABLET / ORALAB2025-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216547-003DASATINIB70MGTABLET / ORALAB2025-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216547-004DASATINIB80MGTABLET / ORALAB2025-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216547-005DASATINIB100MGTABLET / ORALAB2025-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216547-006DASATINIB140MGTABLET / ORALAB2025-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A216547-001DASATINIB20MGTABLET / ORALAB2025-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216547-002DASATINIB50MGTABLET / ORALAB2025-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216547-003DASATINIB70MGTABLET / ORALAB2025-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216547-004DASATINIB80MGTABLET / ORALAB2025-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216547-005DASATINIB100MGTABLET / ORALAB2025-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216547-006DASATINIB140MGTABLET / ORALAB2025-04-226a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216547-001DASATINIB20MGTABLET / ORALAB2025-04-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216547-002DASATINIB50MGTABLET / ORALAB2025-04-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216547-003DASATINIB70MGTABLET / ORALAB2025-04-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216547-004DASATINIB80MGTABLET / ORALAB2025-04-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216547-005DASATINIB100MGTABLET / ORALAB2025-04-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216547-006DASATINIB140MGTABLET / ORALAB2025-04-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216547-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216547-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216547-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216547-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216547-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216547-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216547-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216547-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216547-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216547-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216547-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216547-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216547-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216547-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216547-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216547-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216547-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216547-006AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216547-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216547-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216547-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216547-004AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216547-005AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216547-006AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
DASATINIB
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DASATINIB140 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RBZ1571X5HInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
643105Internal RxNorm lookup
643107Internal RxNorm lookup
643109Internal RxNorm lookup
799047Internal RxNorm lookup
1045402Internal RxNorm lookup
1045406Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
58ce42c6-10bd-4bb4-bf89-eae8ed82c339Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b66e60ef-563e-ddb8-43b4-d625943af44bProduct name320251209
820d87d5-5779-4353-ae7e-33904df346a1Product name120241218

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-547-15DASATINIB15 in 1 BLISTER PACKTABLET151
59651-547-15DASATINIB1 in 1 CARTONTABLET11
59651-547-30DASATINIB30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-547-30EA - Each59651-547a19b743f-8809-4cfa-b69b-d303ceb418fc12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-547DASATINIB TABLET [AUROBINDO PHARMA LIMITED]1Current NDC, 3 package rows20250424_58ce42c6-10bd-4bb4-bf89-eae8ed82c339.zip

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
DASATINIBDASATINIBAurobindo Pharma Limited58ce42c6-10bd-4bb4-bf89-eae8ed82c3392024-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216547
application number: ANDA216547
ndc (product): 59651-547

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
799047dasatinib 100 MG Oral TabletPSN58ce42c6-10bd-4bb4-bf89-eae8ed82c3391
1045402dasatinib 140 MG Oral TabletPSN58ce42c6-10bd-4bb4-bf89-eae8ed82c3391
643105dasatinib 20 MG Oral TabletPSN58ce42c6-10bd-4bb4-bf89-eae8ed82c3391
643107dasatinib 50 MG Oral TabletPSN58ce42c6-10bd-4bb4-bf89-eae8ed82c3391
643109dasatinib 70 MG Oral TabletPSN58ce42c6-10bd-4bb4-bf89-eae8ed82c3391
1045406dasatinib 80 MG Oral TabletPSN58ce42c6-10bd-4bb4-bf89-eae8ed82c3391
799047dasatinib 100 MG Oral TabletSCD58ce42c6-10bd-4bb4-bf89-eae8ed82c3391
1045402dasatinib 140 MG Oral TabletSCD58ce42c6-10bd-4bb4-bf89-eae8ed82c3391
643105dasatinib 20 MG Oral TabletSCD58ce42c6-10bd-4bb4-bf89-eae8ed82c3391
643107dasatinib 50 MG Oral TabletSCD58ce42c6-10bd-4bb4-bf89-eae8ed82c3391
643109dasatinib 70 MG Oral TabletSCD58ce42c6-10bd-4bb4-bf89-eae8ed82c3391
1045406dasatinib 80 MG Oral TabletSCD58ce42c6-10bd-4bb4-bf89-eae8ed82c3391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-547-15596510547151 BLISTER PACK in 1 CARTON (59651-547-15) / 15 TABLET in 1 BLISTER PACK1 blister pack2025-04-22NoNoCurrent
59651-547-305965105473030 TABLET in 1 BOTTLE (59651-547-30) 30 tablet2025-04-22NoNoCurrent