Home NDC 71369-010 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219696-001 DOPTELET SPRINKLE AVATROMBOPAG MALEATE EQ 10MG BASE GRANULE / ORAL RLD, RS 2025-07-24
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219696-001 7638536 2027-07-28 Drug substance, Drug product 2025-08-05
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N219696-001 NP 2028-07-24 N219696-001 ODE-548 2032-07-24
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N219696-001 DOPTELET SPRINKLE EQ 10MG BASE GRANULE / ORAL RLD, RS 2025-07-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219696-001 DOPTELET SPRINKLE EQ 10MG BASE GRANULE / ORAL RLD, RS 2025-07-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219696-001 DOPTELET SPRINKLE EQ 10MG BASE GRANULE / ORAL RLD, RS 2025-07-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219696-001 DOPTELET SPRINKLE EQ 10MG BASE GRANULE / ORAL RLD, RS 2025-07-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219696-001 DOPTELET SPRINKLE EQ 10MG BASE GRANULE / ORAL RLD, RS 2025-07-24 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219696-001 DOPTELET SPRINKLE EQ 10MG BASE GRANULE / ORAL RLD, RS 2025-07-24 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N219696-001 7638536 2027-07-28 Drug substance, Drug product 2025-08-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219696-001 7638536 2027-07-28 Drug substance, Drug product 2025-08-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219696-001 7638536 2027-07-28 Drug substance, Drug product 2025-08-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219696-001 7638536 2027-07-28 Drug substance, Drug product 2025-08-05 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219696-001 7638536 2027-07-28 Drug substance, Drug product 2025-08-05 a50c72e98297…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Doptelet Sprinkle
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVATROMBOPAG MALEATE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination GDW7M2P1IS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2045951 Internal RxNorm lookup 2045952 Internal RxNorm lookup 2045958 Internal RxNorm lookup 2045959 Internal RxNorm lookup 2045960 Internal RxNorm lookup 2045961 Internal RxNorm lookup 2721188 Internal RxNorm lookup 2721192 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71369-010-30 Doptelet Sprinkle 30 in 1 BOTTLE GRANULE 30 21 71369-010-30 Doptelet Sprinkle 1 in 1 CARTON GRANULE 1 21
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71369-010-30 71369001030 1 BOTTLE in 1 CARTON (71369-010-30) / 30 GRANULE in 1 BOTTLE 1 bottle 2025-07-25 No No Current