FDA.reportPublic FDA data

NDC 80425-0552-01 - Pantoprazole

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0552
Requested NDC
80425-0552-01
Package NDCs from labels
80425-0552-1, 80425-0552-2, 80425-0552-3, 80425-0552-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-10-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pantoprazole - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2025-10-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0552-1Pantoprazole30 in 1 BOTTLETABLET, DELAYED RELEASE301
80425-0552-2Pantoprazole60 in 1 BOTTLETABLET, DELAYED RELEASE601
80425-0552-3Pantoprazole90 in 1 BOTTLETABLET, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0552-1EA - Each80425-055299f194e8-c1e8-49b9-a891-42ce862d174a12025-12-16
80425-0552-2EA - Each80425-05522c302f20-a34a-4a75-82a3-5d7a52c907b112025-12-16
80425-0552-3EA - Each80425-05521cc89bbe-88ea-4361-96d2-eba42a53551812025-12-16

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 9 of 295 · 5,881 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FRESH FEELS HAND SANITIZER MIST ICED CHERRY SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedeba7108c-7d96-4393-9444-b3ce2ec7a0602026-08-13WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST BERRY SPRINKLE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited08deb4c2-4ba4-4ec0-b2d2-5cc7f851df4b2026-08-13WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST BERRY SPRINKLE SWIRL SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited424454c9-c1d3-46ec-b186-9159c29f7a4a2026-08-13WarningsExact identifier
unii: 3K9958V90M
Zep Alcohol SanitizerETHANOLZep Inc.b932a59c-a739-5441-e053-2a95a90a4cfa2026-08-13WarningsExact identifier
unii: 3K9958V90M
Zep Fuzion Instant Hand SanitizerALCOHOLZep Inc.b43c5701-22ee-1de4-e053-2995a90a8f642026-08-13WarningsExact identifier
unii: 3K9958V90M
Zep Instant Hand Sanitizer GelALCOHOLZep Inc.b0ee8023-0128-56d6-e053-2a95a90ab4ed2026-08-13WarningsExact identifier
unii: 3K9958V90M
Zep Instant Hand Sanitizer GelALCOHOLZep Inc.b0ed98cd-871b-d862-e053-2995a90a14cc2026-08-13WarningsExact identifier
unii: 3K9958V90M
AFCO 5511 Sanifect E3ETHANOLZep Inc.34795eba-9ec4-6401-e063-6394a90af4282026-08-13WarningsExact identifier
unii: 3K9958V90M
Alcohol Hand SanitizerETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fa90dc-c3b5-787b-e063-6294a90a2e172026-08-13WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Mango Coconut CreamALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58faa781-520b-92fa-e063-6294a90a9ecf2026-08-13WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST COCONUT VANILLA SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited89dd227a-365f-4d8b-b21a-4f1c1b5c9c0a2026-08-13WarningsExact identifier
unii: 3K9958V90M
SprinJeneALCOHOLHealth and Natural Beauty USA Corp1853f023-f4db-4cd8-a4df-a439bc306cc32026-08-13WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST WATERMELON POP SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited3fea32bb-98ec-4dc6-97d3-c77d8e476c042026-08-13WarningsExact identifier
unii: 3K9958V90M
Pantoprazole SodiumPANTOPRAZOLE SODIUMRedpharm Drug58d32be2-166e-1a64-e063-6394a90a26ea2026-08-12Warnings, Adverse reactionsExact identifier
rxcui: 314200
unii: 6871619Q5X
WhiskCare 373ALCOHOLWhisk Products, Inc.57d5cd5d-8597-ce66-e063-6394a90a00472026-08-12WarningsExact identifier
unii: 3K9958V90M
ZoviroALCOHOLZoviro, LLC9c8ca084-8aef-4616-8d51-aaff3eb253432026-08-12WarningsExact identifier
unii: 3K9958V90M
PantoprazolePANTOPRAZOLEPreferred Pharmaceuticals Inc.bb1e79ad-ff52-4696-8743-523f793b29d32026-08-11Warnings, Adverse reactionsExact identifier
application number: ANDA077619
rxcui: 251872
unii: 6871619Q5X
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: 45P3261C7T
LUXURY IPA 70%LUXURY ISOPROPYL ALCOHOL 70% 16OZTSM BRANDS LLC2240a9e0-dac5-54fa-e063-6394a90a35f52026-08-11WarningsExact identifier
unii: ND2M416302
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.