FDA.reportPublic FDA data

Doptelet Sprinkle

Product NDC
71369-010
11-digit product format
713690010
Labeler code
71369
Product ID
71369-010_4d4d84be-34cd-4027-b69a-2f16ec5049ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
avatrombopag
Dosage form
GRANULE
Route
ORAL
Labeler
AkaRx, Inc.
Application
NDA219696
Marketing category
NDA
Marketing start
2025-07-25
Substance
AVATROMBOPAG MALEATE
Active strength
10 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 Sprinkle
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVATROMBOPAG MALEATE10 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
71369-010-30Doptelet Sprinkle30 in 1 BOTTLEGRANULE3021
71369-010-30Doptelet Sprinkle1 in 1 CARTONGRANULE121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71369-010-30EA - Each71369-010ec48ba47-8340-42b1-b3e8-6a358186c92412025-10-14

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 startSampleExclude flagStatus
71369-010-30713690010301 BOTTLE in 1 CARTON (71369-010-30) / 30 GRANULE in 1 BOTTLE1 bottle2025-07-25NoNoHistorical