FDA.reportPublic FDA data

NDC 67457-433-00 - Famotidine

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
67457-433
Requested NDC
67457-433-00
Package NDCs from labels
67457-433-00, 67457-433-22
Manufacturer
Medical Purchasing Solutions, LLC
Effective date
2023-05-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Famotidine - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-05-04HUMAN PRESCRIPTION DRUG LABEL
Famotidine - Mylan Institutional LLCMylan Institutional LLC2022-06-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-433-00Famotidine2 mL in 1 VIALINJECTION26
67457-433-22Famotidine25 in 1 CARTONINJECTION256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-433FAMOTIDINE INJECTION [MYLAN INSTITUTIONAL LLC]5Current NDC, Legacy NDC, 2 package rows20201219_e3b13e23-122b-4bd4-95cf-b5a14b7afc05.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-433-00ML - Milliliter67457-43318848cf6-61e5-477a-b6fb-1dfffd1928b212014-04-03
67457-433-22ML - Milliliter67457-433e8c35555-5311-47f6-a31b-09da762e77e912014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE INJECTION [MYLAN INSTITUTIONAL LLC ]2
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE INJECTION [MYLAN INSTITUTIONAL LLC ]2
ASPARTIC ACIDINACTIVE INGREDIENT30KYC7MIAIFAMOTIDINE INJECTION [MYLAN INSTITUTIONAL LLC ]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHFAMOTIDINE INJECTION [MYLAN INSTITUTIONAL LLC ]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AFAMOTIDINE INJECTION [MYLAN INSTITUTIONAL LLC ]2
WATERINACTIVE INGREDIENT059QF0KO0RFAMOTIDINE INJECTION [MYLAN INSTITUTIONAL LLC ]2

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 5 of 29 · 573 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINECardinal Health 107, LLC5d515c2a-dac9-42d8-aede-66d28a427dbc2026-05-11Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
PlenamineLYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, AND TYROSINEB. Braun Medical Inc.a3244d1a-45b0-4e4c-bd96-f0632d761a1f2026-05-08Warnings, Adverse reactionsExact identifier
unii: 30KYC7MIAI
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: LKG8494WBH
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
FAMOTIDINEFAMOTIDINEST. MARY'S MEDICAL PARK PHARMACYfebe39b1-9212-a281-e053-6394a90a1a9f2026-05-01Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINECardinal Health 107, LLCcdd5dfb7-4efb-4235-8023-5ce145c090382026-04-27Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEREMEDYREPACK INC.8dbf43e0-856f-443b-b8a4-c69e006878ea2026-04-24Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Acid ControllerFAMOTIDINEWalgreen Company42392cb1-7958-4a2f-8622-f00f02afd9612026-04-24WarningsExact identifier
unii: 5QZO15J2Z8
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
FAMOTIDINEFAMOTIDINEPreferred Pharmaceuticals Inc.b445a613-eaa8-45e8-be1f-5848bfd1dd362026-04-15Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEPreferred Pharmaceuticals, Inc.b1edf3c5-e42c-471b-8771-6c93094822de2026-04-15Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FAMOTIDINEFAMOTIDINEPreferred Pharmaceuticals Inc.dbf94314-3a34-4f03-80b1-296559b7d6a52026-04-15Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
COMPLETE ACID REDUCERFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED6ccc03bd-3f36-452a-8945-b3d71cce82412026-04-08WarningsExact identifier
unii: 5QZO15J2Z8
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEPHOENIX RX LLC4ee3e849-2197-8883-e063-6394a90a17482026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
acid controllerFAMOTIDINECVS Pharmacy1531aa51-02e9-45ed-99aa-53b21732dd2e2026-04-06WarningsExact identifier
unii: 5QZO15J2Z8
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
FAMOTIDINEFAMOTIDINEREMEDYREPACK INC.3ab235f4-da59-4a92-ad6b-c76cf3ecd9852026-04-02Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEMedical Purchasing Solutions, LLC4e803491-8030-50d0-e063-6294a90a5c8d2026-04-02Warnings, Adverse reactionsExact identifier
rxcui: 1743833
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEBryant Ranch Prepack545d5c1f-ec1c-4135-965f-333ad888d96f2026-03-31Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8

Reported adverse events (FAERS/openFDA)#

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