Home NDC 71369-020 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 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 N210238-001 DOPTELET AVATROMBOPAG MALEATE EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21
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 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N210238-001 ODE-246 2026-06-26 N210238-001 I-974 2028-07-24 N210238-001 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.
Product history page 1 of 2 · 43 observed 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 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210238-001 DOPTELET EQ 20MG BASE TABLET / ORAL RLD, RS 2018-05-21 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 3 · 113 observed states.
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 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210238-001 7638536 2027-07-28 Drug substance, Drug product 2018-06-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210238-001 8765764 2023-01-15 U-2314 2018-06-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210238-001 8765764 2023-01-15 U-2578 2018-06-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210238-001 8338429 2023-06-30 U-2577 2019-07-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210238-001 7638536 2025-05-05 Drug substance, Drug product 2018-06-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210238-001 8765764 2023-01-15 U-2314 2018-06-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N210238-001 8765764 2023-01-15 U-2578 2018-06-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N210238-001 8338429 2023-06-30 U-2577 2019-07-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N210238-001 7638536 2025-05-05 Drug substance, Drug product 2018-06-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210238-001 8765764 2023-01-15 U-2314 2018-06-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N210238-001 8765764 2023-01-15 U-2578 2018-06-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N210238-001 8338429 2023-06-30 U-2577 2019-07-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N210238-001 7638536 2025-05-05 Drug substance, Drug product 2018-06-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210238-001 8765764 2023-01-15 U-2578 2018-06-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210238-001 8765764 2023-01-15 U-2314 2018-06-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210238-001 8338429 2023-06-30 U-2577 2019-07-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210238-001 7638536 2025-05-05 Drug substance, Drug product 2018-06-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210238-001 8765764 2023-01-15 U-2578 2018-06-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N210238-001 8765764 2023-01-15 U-2314 2018-06-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N210238-001 8338429 2023-06-30 U-2577 2019-07-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N210238-001 7638536 2025-05-05 Drug substance, Drug product 2018-06-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210238-001 8765764 2023-01-15 U-2314 2018-06-15 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N210238-001 8765764 2023-01-15 U-2578 2018-06-15 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N210238-001 8338429 2023-06-30 U-2577 2019-07-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N210238-001 7638536 2025-05-05 Drug substance, Drug product 2018-06-15 782e0a99824c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 91 observed states.
Additional Listing Data#
Finished product Yes
Brand name base DOPTELET
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVATROMBOPAG MALEATE 20 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 71369-020-10 DOPTELET 1 in 1 CARTON TABLET, FILM COATED 1 21 71369-020-11 DOPTELET 10 in 1 BLISTER PACK TABLET, FILM COATED 10 21 71369-020-15 DOPTELET 1 in 1 CARTON TABLET, FILM COATED 1 21 71369-020-16 DOPTELET 15 in 1 BLISTER PACK TABLET, FILM COATED 15 21 71369-020-30 DOPTELET 2 in 1 CARTON TABLET, FILM COATED 2 21
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71369-020 DOPTELET (AVATROMBOPAG MALEATE) TABLET, FILM COATED [AKARX, INC.] 19 Current NDC, Legacy NDC, 5 package rows 20240730_e2d5960d-6c18-46cc-86bd-089222b09852.zip
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 Marketing end Sample Exclude flag Status 71369-020-10 71369002010 1 BLISTER PACK in 1 CARTON (71369-020-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-11) 1 blister pack 2018-05-23 0000-00-00 No No Current 71369-020-11 71369002011 10 in 1 BLISTER PACK Historical 71369-020-15 71369002015 1 BLISTER PACK in 1 CARTON (71369-020-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-16) 1 blister pack 2018-05-23 0000-00-00 No No Current 71369-020-16 71369002016 15 in 1 BLISTER PACK Historical 71369-020-30 71369002030 2 BLISTER PACK in 1 CARTON (71369-020-30) / 15 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-16) 2 blister pack 2019-06-26 0000-00-00 No No Current