Home NDC 81520-250 VOQUEZNA DUAL PAK
Product NDC 81520-250
11-digit product format 815200250
Labeler code 81520
Product ID 81520-250_09164411-fd35-40b3-a208-ac9492cbc201
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vonoprazan fumarate and amoxicillin
Dosage form KIT
Labeler Phathom Pharmaceuticals Inc.
Application NDA215153
Marketing category NDA
Marketing start 2023-11-08
NDC exclude flag No
Listing certified through 2027-12-31
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 N215153-001 VOQUEZNA DUAL PAK AMOXICILLIN; VONOPRAZAN FUMARATE 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215153-001 7977488 2030-04-10 Drug substance 2022-07-27 N215153-001 9186411 2030-08-11 Drug product 2022-07-27
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215153-001 NCE 2027-05-03 N215153-001 GAIN 2032-05-03
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 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD 2022-05-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD 2022-05-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD 2022-05-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD 2022-05-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD 2022-05-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD 2022-05-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215153-001 VOQUEZNA DUAL PAK 500MG;EQ 20MG BASE CAPSULE, TABLET / ORAL RLD, RS 2022-05-03 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 58 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 N215153-001 7977488 2030-04-10 Drug substance 2022-07-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215153-001 7977488 2030-04-10 Drug substance 2022-07-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215153-001 7977488 2030-04-10 Drug substance 2022-07-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215153-001 7977488 2028-08-11 Drug substance 2022-07-27 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215153-001 9186411 2030-08-11 Drug product 2022-07-27 a72a2bbeb626…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 62 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base VOQUEZNA DUAL PAK
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 7 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197517 Internal RxNorm lookup 308191 Internal RxNorm lookup 2604800 Internal RxNorm lookup 2604801 Internal RxNorm lookup 2604802 Internal RxNorm lookup 2604803 Internal RxNorm lookup 2604804 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 81520-250-01 VOQUEZNA DUAL PAK 1 in 1 BLISTER PACK KIT 1 16 81520-250-14 VOQUEZNA DUAL PAK 14 in 1 CARTON KIT 14 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81520-250 VOQUEZNA DUAL PAK (VONOPRAZAN FUMARATE AND AMOXICILLIN) KIT VOQUEZNA TRIPLE PAK (VONOPRAZAN FUMARATE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHATHOM PHARMACEUTICALS INC.] 13 Current NDC, Legacy NDC, 2 package rows 20250524_0cb2ee04-8581-46c8-a781-7be170ab5c86.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 81520-250-01 81520025001 1 in 1 BLISTER PACK Historical 81520-250-14 81520025014 14 BLISTER PACK in 1 CARTON (81520-250-14) / 1 KIT in 1 BLISTER PACK (81520-250-01) 14 blister pack 2023-11-08 0000-00-00 No No Current