Dasatinib Tablets for Oral Use

Manufacturer
Zydus Lifesciences Limited
Effective date
2025-03-04
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 21:27:10

Label at a glance#

Productdasatinib
Active ingredientDASATINIB
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1901-6

Dasatinib Tablets, 20 mg

60 Tablets

Rx only

Zydus

20 mg
20 mg

NDC 70771-1902-6

Dasatinib Tablets, 50 mg

60 Tablets

Rx only

Zydus

50 mg
50 mg

NDC 70771-1903-6

Dasatinib Tablets, 70 mg

60 Tablets

Rx only

Zydus

70 mg
70 mg

NDC 70771-1904-3

Dasatinib Tablets, 80 mg

30 Tablets

Rx only

Zydus

80 mg
80 mg

NDC 70771-1905-3

Dasatinib Tablets, 100 mg

30 Tablets

Rx only

Zydus

100 mg
100 mg

NDC 70771-1906-3

Dasatinib Tablets, 140 mg

30 Tablets

Rx only

Zydus

140 mg
140 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
799047dasatinib 100 MG Oral TabletPSN1
1045402dasatinib 140 MG Oral TabletPSN1
643105dasatinib 20 MG Oral TabletPSN1
643107dasatinib 50 MG Oral TabletPSN1
643109dasatinib 70 MG Oral TabletPSN1
1045406dasatinib 80 MG Oral TabletPSN1
799047dasatinib 100 MG Oral TabletSCD1
1045402dasatinib 140 MG Oral TabletSCD1
643105dasatinib 20 MG Oral TabletSCD1
643107dasatinib 50 MG Oral TabletSCD1
643109dasatinib 70 MG Oral TabletSCD1
1045406dasatinib 80 MG Oral TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DASATINIB ANHYDROUS Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813

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
70771-1901-6dasatinib60 in 1 BOTTLETABLET601
70771-1902-6dasatinib60 in 1 BOTTLETABLET601
70771-1903-6dasatinib60 in 1 BOTTLETABLET601
70771-1904-3dasatinib30 in 1 BOTTLETABLET301
70771-1905-3dasatinib30 in 1 BOTTLETABLET301
70771-1906-3dasatinib30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1901DASATINIB TABLET [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 1 package rows20250309_4eed6b7b-a09d-4d2e-a345-968dd68323bc.zip
70771-1902DASATINIB TABLET [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 1 package rows20250309_4eed6b7b-a09d-4d2e-a345-968dd68323bc.zip
70771-1903DASATINIB TABLET [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 1 package rows20250309_4eed6b7b-a09d-4d2e-a345-968dd68323bc.zip
70771-1904DASATINIB TABLET [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 1 package rows20250309_4eed6b7b-a09d-4d2e-a345-968dd68323bc.zip
70771-1905DASATINIB TABLET [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 1 package rows20250309_4eed6b7b-a09d-4d2e-a345-968dd68323bc.zip
70771-1906DASATINIB TABLET [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 1 package rows20250309_4eed6b7b-a09d-4d2e-a345-968dd68323bc.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 72 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A218719-001DASATINIBDASATINIB20MGTABLET / ORALAB2025-03-03
A218719-002DASATINIBDASATINIB50MGTABLET / ORALAB2025-03-03
A218719-003DASATINIBDASATINIB70MGTABLET / ORALAB2025-03-03
A218719-004DASATINIBDASATINIB80MGTABLET / ORALAB2025-03-03
A218719-005DASATINIBDASATINIB100MGTABLET / ORALAB2025-03-03
A218719-006DASATINIBDASATINIB140MGTABLET / 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
A218719-001AB
A218719-002AB
A218719-003AB
A218719-004AB
A218719-005AB
A218719-006AB

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A218719-001DASATINIB20MGTABLET / ORALAB2025-03-0384e616aacf4f…
2026-09-14 22:38:342026-08A218719-002DASATINIB50MGTABLET / ORALAB2025-03-0384e616aacf4f…
2026-09-14 22:38:342026-08A218719-003DASATINIB70MGTABLET / ORALAB2025-03-0384e616aacf4f…
2026-09-14 22:38:342026-08A218719-004DASATINIB80MGTABLET / ORALAB2025-03-0384e616aacf4f…
2026-09-14 22:38:342026-08A218719-005DASATINIB100MGTABLET / ORALAB2025-03-0384e616aacf4f…
2026-09-14 22:38:342026-08A218719-006DASATINIB140MGTABLET / ORALAB2025-03-0384e616aacf4f…
2026-08-18 06:07:402026-07A218719-001DASATINIB20MGTABLET / ORALAB2025-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07A218719-002DASATINIB50MGTABLET / ORALAB2025-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07A218719-003DASATINIB70MGTABLET / ORALAB2025-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07A218719-004DASATINIB80MGTABLET / ORALAB2025-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07A218719-005DASATINIB100MGTABLET / ORALAB2025-03-03caaa826d4ba7…
2026-08-18 06:07:402026-07A218719-006DASATINIB140MGTABLET / ORALAB2025-03-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218719-001DASATINIB20MGTABLET / ORALAB2025-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218719-002DASATINIB50MGTABLET / ORALAB2025-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218719-003DASATINIB70MGTABLET / ORALAB2025-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218719-004DASATINIB80MGTABLET / ORALAB2025-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218719-005DASATINIB100MGTABLET / ORALAB2025-03-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218719-006DASATINIB140MGTABLET / ORALAB2025-03-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218719-001DASATINIB20MGTABLET / ORALAB2025-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218719-002DASATINIB50MGTABLET / ORALAB2025-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218719-003DASATINIB70MGTABLET / ORALAB2025-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218719-004DASATINIB80MGTABLET / ORALAB2025-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218719-005DASATINIB100MGTABLET / ORALAB2025-03-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218719-006DASATINIB140MGTABLET / ORALAB2025-03-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A218719-001DASATINIB20MGTABLET / ORALAB2025-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218719-002DASATINIB50MGTABLET / ORALAB2025-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218719-003DASATINIB70MGTABLET / ORALAB2025-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218719-004DASATINIB80MGTABLET / ORALAB2025-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218719-005DASATINIB100MGTABLET / ORALAB2025-03-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218719-006DASATINIB140MGTABLET / ORALAB2025-03-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218719-001DASATINIB20MGTABLET / ORALAB2025-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218719-002DASATINIB50MGTABLET / ORALAB2025-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218719-003DASATINIB70MGTABLET / ORALAB2025-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218719-004DASATINIB80MGTABLET / ORALAB2025-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218719-005DASATINIB100MGTABLET / ORALAB2025-03-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218719-006DASATINIB140MGTABLET / ORALAB2025-03-03fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218719-001DASATINIB20MGTABLET / ORALAB2025-03-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218719-002DASATINIB50MGTABLET / ORALAB2025-03-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218719-003DASATINIB70MGTABLET / ORALAB2025-03-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218719-004DASATINIB80MGTABLET / ORALAB2025-03-03a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A218719-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A218719-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A218719-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A218719-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A218719-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A218719-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A218719-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218719-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218719-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218719-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218719-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218719-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218719-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218719-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218719-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218719-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218719-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218719-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218719-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218719-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218719-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218719-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218719-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218719-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218719-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218719-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218719-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218719-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218719-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218719-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218719-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218719-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218719-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218719-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218719-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218719-006AB1fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218719-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218719-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218719-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218719-004AB1a50c72e98297…

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
dasatinibDASATINIBZydus Lifesciences Limited4eed6b7b-a09d-4d2e-a345-968dd68323bc2025-03-04Exact identifier
ndc (package): 70771-1904-3
ndc (package): 70771-1902-6
ndc (package): 70771-1906-3
ndc (package): 70771-1905-3
ndc (package): 70771-1901-6
ndc (package): 70771-1903-6
ndc (product): 70771-1906
ndc (product): 70771-1901
ndc (product): 70771-1903
ndc (product): 70771-1902
ndc (product): 70771-1905
ndc (product): 70771-1904
ndc11 (package): 70771190306
ndc11 (package): 70771190106
ndc11 (package): 70771190503
ndc11 (package): 70771190603
ndc11 (package): 70771190403
ndc11 (package): 70771190206
spl id: 571889d7-845d-4fed-8d7d-6470d4d36fa1
spl set id: 4eed6b7b-a09d-4d2e-a345-968dd68323bc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.