FDA.reportPublic FDA data

DOPTELET

Product NDC
71369-020
11-digit product format
713690020
Labeler code
71369
Product ID
71369-020_4d4d84be-34cd-4027-b69a-2f16ec5049ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
avatrombopag maleate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AkaRx, Inc.
Application
NDA210238
Marketing category
NDA
Marketing start
2018-05-23
Substance
AVATROMBOPAG MALEATE
Active strength
20 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVATROMBOPAG MALEATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGDW7M2P1IS
Rxcui2045951, 2045952, 2045958, 2045959, 2045960, 2045961, 2721188, 2721192

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
556d0111-290d-44d5-b0f2-3129e334a9aaProduct name120180726

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71369-020-10DOPTELET1 in 1 CARTONTABLET, FILM COATED121
71369-020-11DOPTELET10 in 1 BLISTER PACKTABLET, FILM COATED1021
71369-020-15DOPTELET1 in 1 CARTONTABLET, FILM COATED121
71369-020-16DOPTELET15 in 1 BLISTER PACKTABLET, FILM COATED1521
71369-020-30DOPTELET2 in 1 CARTONTABLET, FILM COATED221

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71369-020-10EA - Each71369-0205222cd92-9ab6-405c-bb50-74344d5b525f12018-06-11
71369-020-11EA - Each71369-02036ff7778-e8d0-416c-873b-12371e20681a12022-06-06
71369-020-15EA - Each71369-020cdedfe70-ebfc-4cc6-9856-cf04004fca0c12018-06-11
71369-020-16EA - Each71369-020788c4b2f-02e4-43c3-912e-3a212f4601db12022-06-06
71369-020-30EA - Each71369-020ec42beaa-c8f3-4527-9815-efb706a9cec812019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71369-020DOPTELET (AVATROMBOPAG MALEATE) TABLET, FILM COATED [AKARX, INC.]19Current NDC, Legacy NDC, 5 package rows20240730_e2d5960d-6c18-46cc-86bd-089222b09852.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2045959{10 (avatrombopag 20 MG Oral Tablet [Doptelet]) } Pack [Doptelet 40 MG Daily Dose Carton]BPCKe2d5960d-6c18-46cc-86bd-089222b0985221
2045961{15 (avatrombopag 20 MG Oral Tablet [Doptelet]) } Pack [Doptelet 60 MG Daily Dose Carton]BPCKe2d5960d-6c18-46cc-86bd-089222b0985221
2045952{10 (avatrombopag 20 MG Oral Tablet) } PackGPCKe2d5960d-6c18-46cc-86bd-089222b0985221
2045960{15 (avatrombopag 20 MG Oral Tablet) } PackGPCKe2d5960d-6c18-46cc-86bd-089222b0985221
2721188avatrombopag 10 MG Oral GranulesPSNe2d5960d-6c18-46cc-86bd-089222b0985221
2045951avatrombopag 20 MG Oral TabletPSNe2d5960d-6c18-46cc-86bd-089222b0985221
2045952avatrombopag 40 MG Daily Dose, 20 MG Oral Tablet 10 Count PackPSNe2d5960d-6c18-46cc-86bd-089222b0985221
2045960avatrombopag 60 MG Daily Dose, 20 MG Oral Tablet 15 Count PackPSNe2d5960d-6c18-46cc-86bd-089222b0985221
2045958Doptelet 20 MG Oral TabletPSNe2d5960d-6c18-46cc-86bd-089222b0985221
2045959Doptelet 40 MG Daily Dose Carton PackPSNe2d5960d-6c18-46cc-86bd-089222b0985221
2045961Doptelet 60 MG Daily Dose Carton PackPSNe2d5960d-6c18-46cc-86bd-089222b0985221
2721192Doptelet Sprinkle 10 MG Oral GranulesPSNe2d5960d-6c18-46cc-86bd-089222b0985221
2721192avatrombopag 10 MG Oral Granules [Doptelet]SBDe2d5960d-6c18-46cc-86bd-089222b0985221
2045958avatrombopag 20 MG Oral Tablet [Doptelet]SBDe2d5960d-6c18-46cc-86bd-089222b0985221
2721188avatrombopag 10 MG Oral GranulesSCDe2d5960d-6c18-46cc-86bd-089222b0985221
2045951avatrombopag 20 MG Oral TabletSCDe2d5960d-6c18-46cc-86bd-089222b0985221
2721188avatrombopag 10 MG (equivalent to avatrombopag maleate 11.787 MG) Oral GranulesSYe2d5960d-6c18-46cc-86bd-089222b0985221
2045951avatrombopag 20 MG (as avatrombopag maleate 23.6 MG) Oral TabletSYe2d5960d-6c18-46cc-86bd-089222b0985221
2045952avatrombopag 40 MG Daily Dose Carton Pack, 1 Blister Card, 10 Tablets EachSYe2d5960d-6c18-46cc-86bd-089222b0985221
2045960avatrombopag 60 MG Daily Dose Carton Pack, 1 Blister Card, 15 Tablets EachSYe2d5960d-6c18-46cc-86bd-089222b0985221
2045958Doptelet 20 MG Oral TabletSYe2d5960d-6c18-46cc-86bd-089222b0985221
2045959Doptelet 40 MG Daily Dose Carton PackSYe2d5960d-6c18-46cc-86bd-089222b0985221
2045961Doptelet 60 MG Daily Dose Carton PackSYe2d5960d-6c18-46cc-86bd-089222b0985221
2721192Doptelet Sprinkle 10 MG (equivalent to avatrombopag maleate 11.787 MG) Oral GranulesSYe2d5960d-6c18-46cc-86bd-089222b0985221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71369-020-10713690020101 BLISTER PACK in 1 CARTON (71369-020-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-11) 1 blister pack2018-05-230000-00-00NoNoCurrent
71369-020-117136900201110 in 1 BLISTER PACKHistorical
71369-020-15713690020151 BLISTER PACK in 1 CARTON (71369-020-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-16) 1 blister pack2018-05-230000-00-00NoNoCurrent
71369-020-167136900201615 in 1 BLISTER PACKHistorical
71369-020-30713690020302 BLISTER PACK in 1 CARTON (71369-020-30) / 15 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-16) 2 blister pack2019-06-260000-00-00NoNoCurrent