FDA.reportPublic FDA data

VOQUEZNA DUAL PAK

Product NDC
81520-250
11-digit product format
815200250
Labeler code
81520
Product ID
81520-250_5acd62cf-6c95-479f-9cab-22febc716a4f
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VOQUEZNA DUAL PAK
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui197517, 308191, 2604800, 2604801, 2604802, 2604803, 2604804

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
ec567ae0-eedb-46c6-8d48-5818685294f7Product name120250307
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
e3d1ac4d-bee8-bcec-c4e6-12004dcb6ab2Product name720221114
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81520-250-01VOQUEZNA DUAL PAK1 in 1 BLISTER PACKKIT116
81520-250-14VOQUEZNA DUAL PAK14 in 1 CARTONKIT1416

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81520-250-01EA - Each81520-25096083106-c852-4d9e-b36e-d2bda8cabcdf12022-06-06
81520-250-14EA - Each81520-25089346b89-d76c-4485-a169-c266c00baa1112022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81520-250VOQUEZNA DUAL PAK (VONOPRAZAN FUMARATE AND AMOXICILLIN) KIT VOQUEZNA TRIPLE PAK (VONOPRAZAN FUMARATE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHATHOM PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 2 package rows20250524_0cb2ee04-8581-46c8-a781-7be170ab5c86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2604804{56 (amoxicillin 500 MG Oral Capsule) / 28 (clarithromycin 500 MG Oral Tablet) / 28 (vonoprazan 20 MG Oral Tablet) } Pack [Voquezna 14 Day TriplePak 20;500;500]BPCK0cb2ee04-8581-46c8-a781-7be170ab5c8616
2604802{84 (amoxicillin 500 MG Oral Capsule) / 28 (vonoprazan 20 MG Oral Tablet) } Pack [Voquezna 14 Day DualPak 20;500]BPCK0cb2ee04-8581-46c8-a781-7be170ab5c8616
2604803{56 (amoxicillin 500 MG Oral Capsule) / 28 (clarithromycin 500 MG Oral Tablet) / 28 (vonoprazan 20 MG Oral Tablet) } PackGPCK0cb2ee04-8581-46c8-a781-7be170ab5c8616
2604801{84 (amoxicillin 500 MG Oral Capsule) / 28 (vonoprazan 20 MG Oral Tablet) } PackGPCK0cb2ee04-8581-46c8-a781-7be170ab5c8616
2604803amoxicillin 500 MG (56) / clarithromycin 500 MG (28) / vonoprazan 20 MG (28) 14 Day TriplePak Oral PackPSN0cb2ee04-8581-46c8-a781-7be170ab5c8616
2604801amoxicillin 500 MG (84) / vonoprazan 20 MG (28) 14 Day DualPak Oral PackPSN0cb2ee04-8581-46c8-a781-7be170ab5c8616
308191amoxicillin 500 MG Oral CapsulePSN0cb2ee04-8581-46c8-a781-7be170ab5c8616
197517clarithromycin 500 MG Oral TabletPSN0cb2ee04-8581-46c8-a781-7be170ab5c8616
2604800vonoprazan 20 MG Oral TabletPSN0cb2ee04-8581-46c8-a781-7be170ab5c8616
2604802Voquezna 14 Day DualPak 20 MG; 500 MGPSN0cb2ee04-8581-46c8-a781-7be170ab5c8616
2604804Voquezna 14 Day TriplePak 20 MG; 500 MG; 500 MGPSN0cb2ee04-8581-46c8-a781-7be170ab5c8616
308191amoxicillin 500 MG Oral CapsuleSCD0cb2ee04-8581-46c8-a781-7be170ab5c8616
197517clarithromycin 500 MG Oral TabletSCD0cb2ee04-8581-46c8-a781-7be170ab5c8616
2604800vonoprazan 20 MG Oral TabletSCD0cb2ee04-8581-46c8-a781-7be170ab5c8616
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY0cb2ee04-8581-46c8-a781-7be170ab5c8616
2604803amoxicillin 500 MG (56) / clarithromycin 500 MG (28) / vonoprazan 20 MG (28) 14 Day TriplePak Oral PackSY0cb2ee04-8581-46c8-a781-7be170ab5c8616
2604801amoxicillin 500 MG (84) / vonoprazan 20 MG (28) 14 Day DualPak Oral PackSY0cb2ee04-8581-46c8-a781-7be170ab5c8616
2604800vonoprazan 20 MG (as vonoprazan fumarate 26.72 mg) Oral TabletSY0cb2ee04-8581-46c8-a781-7be170ab5c8616
2604802Voquezna 14 Day DualPak 20 MG; 500 MG PackSY0cb2ee04-8581-46c8-a781-7be170ab5c8616
2604804Voquezna 14 Day TriplePak 20 MG; 500 MG; 500 MG PackSY0cb2ee04-8581-46c8-a781-7be170ab5c8616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81520-250-01815200250011 in 1 BLISTER PACKHistorical
81520-250-148152002501414 BLISTER PACK in 1 CARTON (81520-250-14) / 1 KIT in 1 BLISTER PACK (81520-250-01) 14 blister pack2023-11-080000-00-00NoNoCurrent