FDA.reportPublic FDA data

NDC 42799-952-01 - Pantoprazole Sodium

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
42799-952
Requested NDC
42799-952-01
Package NDCs from labels
42799-952-01, 42799-952-30
Manufacturer
Edenbridge Pharmaceuticals LLC.
Effective date
2026-07-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pantoprazole Sodium - Edenbridge Pharmaceuticals LLC.Edenbridge Pharmaceuticals LLC.2026-07-22Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42799-952-01Pantoprazole Sodium1 in 1 PACKETGRANULE, DELAYED RELEASE14
42799-952-30Pantoprazole Sodium30 in 1 CARTONGRANULE, DELAYED RELEASE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42799-952PANTOPRAZOLE SODIUM GRANULE, DELAYED RELEASE [EDENBRIDGE PHARMACEUTICALS LLC.]3Current NDC, 2 package rows20230912_a0bb76bc-094a-4d61-9bb2-2226c9da4ae9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42799-952-01EA - Each42799-952a200ed55-600b-4525-9427-aa61691d54c412023-09-05
42799-952-30EA - Each42799-9527025722f-4af1-4160-b76d-87fe576e61fd12023-09-05

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 14 · 263 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pantoprazole sodiumPANTOPRAZOLE SODIUMCamber Pharmaceuticals, Inc.1bb94d3c-8bc3-4193-9dd8-e9a22066707c2026-08-31Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEAvPAK59f50bcb-85e5-e3f6-e063-6294a90a11ae2026-08-26Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Pantoprazole SodiumPANTOPRAZOLE SODIUMRedpharm Drug58d32be2-166e-1a64-e063-6394a90a26ea2026-08-12Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PantoprazolePANTOPRAZOLEPreferred Pharmaceuticals Inc.bb1e79ad-ff52-4696-8743-523f793b29d32026-08-11Warnings, Adverse reactionsExact identifier
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
PANTOPRAZOLE SODIUMPANTOPRAZOLEPreferred Pharmaceuticals Inc.5c14e2f3-625d-4089-a404-440b0ecf72e72026-08-11Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMAmerican Health Packaging5ff3cf6c-6f0a-4374-8b80-4e1eb1df62452026-08-07Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMCardinal Health 107, LLCe17e4a72-d6a4-4a83-a921-88af9ef028a62026-07-30Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMEdenbridge Pharmaceuticals LLC.a0bb76bc-094a-4d61-9bb2-2226c9da4ae92026-07-22Warnings, Adverse reactionsExact identifier
application number: ANDA216247
ndc (package): 42799-952-30
ndc (package): 42799-952-01
ndc (product): 42799-952
ndc11 (package): 42799095201
rxcui: 763306
spl id: 491a4100-ef0e-4a7e-82cd-6f574f416c26
spl set id: a0bb76bc-094a-4d61-9bb2-2226c9da4ae9
unii: 6871619Q5X
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
Pantoprazole SodiumPANTOPRAZOLE SODIUMREMEDYREPACK INC.76e1839b-7462-4344-b319-001a5f57d67a2026-07-14Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMEugia US LLC9bed093a-9586-4c82-a2b7-c68f89d0faef2026-07-09Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMREMEDYREPACK INC.f38a6df2-1dd4-48bf-9ec4-1113ce492e782026-07-03Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMUnit Dose Solutions, Inc.558dc7e1-dfd5-d3d7-e063-6394a90ab9c32026-07-01Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMREMEDYREPACK INC.f313159c-115a-4cf6-b32e-9ddc833fd51c2026-07-01Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLESportpharm LLCb58c376e-616b-4970-a375-52ff630e7f092026-06-29Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMUnit Dose Solutions, Inc.5566b4b1-b4f5-4020-e063-6394a90a52572026-06-29Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEHAWAII REPACK, INC.f85e6d64-1ddc-4f4a-86dc-0749081a6a5f2026-06-27Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMHAWAII REPACK, INC.f403c94d-68b7-43df-8c8e-c9fef3309cfc2026-06-26Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X

Reported adverse events (FAERS/openFDA)#

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