FDA.reportPublic FDA data

Dasatinib

Product NDC
43598-599
11-digit product format
435980599
Labeler code
43598
Product ID
43598-599_ce9ef276-e0b1-4bd7-1e16-06035ef595a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dasatinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr.Reddys Laboratories Inc
Application
ANDA213383
Marketing category
ANDA
Marketing start
2025-03-03
Substance
DASATINIB
Active strength
20 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
A213383-001DASATINIBDASATINIB20MGTABLET / ORALAB2025-03-03
A213383-002DASATINIBDASATINIB50MGTABLET / ORALAB2025-03-03
A213383-003DASATINIBDASATINIB70MGTABLET / ORALAB2025-03-03
A213383-004DASATINIBDASATINIB80MGTABLET / ORALAB2025-03-03
A213383-005DASATINIBDASATINIB100MGTABLET / ORALAB2025-03-03
A213383-006DASATINIBDASATINIB140MGTABLET / ORALAB2025-03-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213383-001AB
A213383-002AB
A213383-003AB
A213383-004AB
A213383-005AB
A213383-006AB

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 UTC2026-02A213383-001DASATINIB20MGTABLET / ORALAB2025-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213383-002DASATINIB50MGTABLET / ORALAB2025-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213383-003DASATINIB70MGTABLET / ORALAB2025-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213383-004DASATINIB80MGTABLET / ORALAB2025-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213383-005DASATINIB100MGTABLET / ORALAB2025-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213383-006DASATINIB140MGTABLET / ORALAB2025-03-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213383-001DASATINIB20MGTABLET / ORALAB2025-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213383-002DASATINIB50MGTABLET / ORALAB2025-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213383-003DASATINIB70MGTABLET / ORALAB2025-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213383-004DASATINIB80MGTABLET / ORALAB2025-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213383-005DASATINIB100MGTABLET / ORALAB2025-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213383-006DASATINIB140MGTABLET / ORALAB2025-03-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A213383-001DASATINIB20MGTABLET / ORALAB2025-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213383-002DASATINIB50MGTABLET / ORALAB2025-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213383-003DASATINIB70MGTABLET / ORALAB2025-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213383-004DASATINIB80MGTABLET / ORALAB2025-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213383-005DASATINIB100MGTABLET / ORALAB2025-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213383-006DASATINIB140MGTABLET / ORALAB2025-03-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213383-001DASATINIB20MGTABLET / ORALAB2025-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213383-002DASATINIB50MGTABLET / ORALAB2025-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213383-003DASATINIB70MGTABLET / ORALAB2025-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213383-004DASATINIB80MGTABLET / ORALAB2025-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213383-005DASATINIB100MGTABLET / ORALAB2025-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213383-006DASATINIB140MGTABLET / ORALAB2025-03-03fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213383-001DASATINIB20MGTABLET / ORALAB2025-03-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213383-002DASATINIB50MGTABLET / ORALAB2025-03-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213383-003DASATINIB70MGTABLET / ORALAB2025-03-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213383-004DASATINIB80MGTABLET / ORALAB2025-03-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213383-005DASATINIB100MGTABLET / ORALAB2025-03-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213383-006DASATINIB140MGTABLET / ORALAB2025-03-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213383-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213383-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213383-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213383-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213383-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213383-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213383-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213383-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213383-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213383-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213383-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213383-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213383-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213383-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213383-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213383-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213383-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213383-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213383-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213383-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213383-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213383-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213383-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213383-006AB1fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213383-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213383-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213383-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213383-004AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213383-005AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213383-006AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DASATINIB20 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
eb5ddff2-6521-b461-43ac-80ff8660b20bAvailable 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
43598-599-60Dasatinib60 in 1 BOTTLETABLET, FILM COATED609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-599-60EA - Each43598-599a19ca622-5e2c-4cc9-9f91-ff5f90212d7212025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-599DASATINIB TABLET, FILM COATED [DR.REDDYS LABORATORIES INC]9Current NDC, 1 package rows20250309_eb5ddff2-6521-b461-43ac-80ff8660b20b.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
DasatinibDASATINIBDr.Reddys Laboratories Inceb5ddff2-6521-b461-43ac-80ff8660b20b2025-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213383
application number: ANDA213383
ndc (product): 43598-599

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
799047dasatinib 100 MG Oral TabletPSNeb5ddff2-6521-b461-43ac-80ff8660b20b9
1045402dasatinib 140 MG Oral TabletPSNeb5ddff2-6521-b461-43ac-80ff8660b20b9
643105dasatinib 20 MG Oral TabletPSNeb5ddff2-6521-b461-43ac-80ff8660b20b9
643107dasatinib 50 MG Oral TabletPSNeb5ddff2-6521-b461-43ac-80ff8660b20b9
643109dasatinib 70 MG Oral TabletPSNeb5ddff2-6521-b461-43ac-80ff8660b20b9
1045406dasatinib 80 MG Oral TabletPSNeb5ddff2-6521-b461-43ac-80ff8660b20b9
799047dasatinib 100 MG Oral TabletSCDeb5ddff2-6521-b461-43ac-80ff8660b20b9
1045402dasatinib 140 MG Oral TabletSCDeb5ddff2-6521-b461-43ac-80ff8660b20b9
643105dasatinib 20 MG Oral TabletSCDeb5ddff2-6521-b461-43ac-80ff8660b20b9
643107dasatinib 50 MG Oral TabletSCDeb5ddff2-6521-b461-43ac-80ff8660b20b9
643109dasatinib 70 MG Oral TabletSCDeb5ddff2-6521-b461-43ac-80ff8660b20b9
1045406dasatinib 80 MG Oral TabletSCDeb5ddff2-6521-b461-43ac-80ff8660b20b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43598-599-604359805996060 TABLET, FILM COATED in 1 BOTTLE (43598-599-60) 2025-03-03NoNoCurrent