NDC 0008-0844-01 - Protonix Delayed-Release

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
0008-0844
Requested NDC
0008-0844-01
Package NDCs from labels
0008-0844-01, 0008-0844-02
Manufacturer
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | AndersonBrecon Inc. | Takeda GmbH
Effective date
2026-05-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PANTOPRAZOLE - Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | AndersonBrecon Inc. | Takeda GmbHWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | AndersonBrecon Inc. | Takeda GmbH2026-05-18HUMAN PRESCRIPTION DRUG LABEL
Protonix Delayed-Release - Cardinal Health 107, LLCCardinal Health 107, LLC2024-10-10HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0008-0844-01ProtonixDelayed-Release1 in 1 PACKETGRANULE, DELAYED RELEASE148
0008-0844-02ProtonixDelayed-Release30 in 1 CARTONGRANULE, DELAYED RELEASE3048

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0008-0844PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]47Current NDC, Legacy NDC, 2 package rows20240719_08098cb2-c048-4640-f387-6beec4a38936.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0008-0844-01EA - Each0008-0844a4a64248-a74b-44f3-85c5-bfd22d4cd46212012-07-24
0008-0844-02EA - Each0008-0844923dad3a-0648-4fe5-b4ea-526fe7657d8d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
MANNITOLINACTIVE INGREDIENT3OWL53L36APROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
TALCINACTIVE INGREDIENT7SEV7J4R1UPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]26
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]8
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]8
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]8
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]8
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]8
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]8
MANNITOLINACTIVE INGREDIENT3OWL53L36APROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]8
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]8
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]8
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]8
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]8
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]8
TALCINACTIVE INGREDIENT7SEV7J4R1UPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]8
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]8

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 43 of 117 · 2,333 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEJOHANNA'S SKIN CARE3544faa1-ebdf-5dbd-e063-6394a90a76312025-12-12Exact identifier
unii: 15FIX9V2JP
Tinted Facial Mineral Sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDERSL89 LLC3531d609-a0d8-cb59-e063-6394a90a4bea2025-12-12Exact identifier
unii: 15FIX9V2JP
Tinted Facial Mineral Sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDERSL89 LLC3532a6a2-dbb5-8111-e063-6294a90aeaeb2025-12-12Exact identifier
unii: 15FIX9V2JP
Tinted Daily Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERSL89 LLC35338026-525a-d8b3-e063-6394a90a98f52025-12-12Exact identifier
unii: 15FIX9V2JP
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDERSL89 LLC3541971e-3664-a9f5-e063-6294a90ac2d22025-12-12Exact identifier
unii: 15FIX9V2JP
Prime Protection Sunscreen non tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS36608832-22d8-bc76-e063-6394a90abac62025-12-12Exact identifier
unii: 15FIX9V2JP
Prime Protection Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS3660af9e-d60f-c33e-e063-6394a90a3a052025-12-12Exact identifier
unii: 15FIX9V2JP
Prime Protection Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS3660e701-1373-eef4-e063-6394a90a61402025-12-12Exact identifier
unii: 15FIX9V2JP
sheer tinted sunscreenTITANIUM DIOXIDE, ZINC OXIDESARA ELIZABETH SKINCARE3b177c49-ed8c-42b9-e063-6294a90a82c62025-12-12WarningsExact identifier
unii: 15FIX9V2JP
Non-Tinted Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3581ab49-ef55-3743-e063-6394a90a3bd52025-12-12Exact identifier
unii: 15FIX9V2JP
Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3581cf33-3520-42f7-e063-6394a90a6f932025-12-12Exact identifier
unii: 15FIX9V2JP
Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3592b2c7-295a-7c60-e063-6394a90a387b2025-12-12Exact identifier
unii: 15FIX9V2JP
Sun Elegant Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDESKIN BY NESRIN3580ae10-1867-cb68-e063-6394a90a72df2025-12-12Exact identifier
unii: 15FIX9V2JP
PROTECTOR SOLAR NON-TINTED SPF SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEThe Beez Kneez Skin Care & Acne Clinic LLC358195c0-6d28-1ffe-e063-6394a90a60272025-12-12Exact identifier
unii: 15FIX9V2JP
Matte Velvet TintTITANIUM DIOXIDE, ZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation3583f860-664b-2658-e063-6394a90a38572025-12-12Exact identifier
unii: 15FIX9V2JP
SPF LipTITANIUM DIOXIDE, ZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation359297cd-10e2-6ddd-e063-6394a90a4aa02025-12-12Exact identifier
unii: 15FIX9V2JP
Matte Velvet TintTITANIUM DIOXIDE, ZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation359641c5-0e19-f243-e063-6394a90aeebc2025-12-12Exact identifier
unii: 15FIX9V2JP
TINTED MINERAL SUNSCREEN SPF 40TITANIUM DIOXIDE, ZINC OXIDEDERMATOLOGY ARTS35814d5d-fd34-05b3-e063-6294a90aadd12025-12-12Exact identifier
unii: 15FIX9V2JP
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELA HAIR DESIGN36eb4cd3-778c-362f-e063-6294a90a059c2025-12-11Exact identifier
unii: 15FIX9V2JP
Matte FinishTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC37630c6c-f768-7b3e-e063-6394a90af5652025-12-11Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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