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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
GDW7M2P1ISAVATROMBOPAG MALEATE677007-74-8AVATROMBOPAG MALEATE
3H8GSZ4SQLAVATROMBOPAG570406-98-3avatrombopag

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71369-010-30713690010301 BOTTLE in 1 CARTON (71369-010-30) / 30 GRANULE in 1 BOTTLE1 bottle2025-07-25NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DOPTELETAkaRx, Inc.2025-08-13HUMAN PRESCRIPTION DRUG LABEL21