NDC 0641-6022-01 - 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
0641-6022
Requested NDC
0641-6022-01
Package NDCs from labels
0641-6022-01, 0641-6022-25
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2024-04-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Famotidine Injection, USPHikma Pharmaceuticals USA Inc.2024-04-09HUMAN PRESCRIPTION DRUG LABEL
Famotidine - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-05-08HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6022-01Famotidine2 mL in 1 VIALINJECTION29
0641-6022-25Famotidine25 in 1 CARTONINJECTION259

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6022FAMOTIDINE INJECTION [HIKMA PHARMACEUTICALS USA INC.]9Current NDC, Legacy NDC, 2 package rows20240410_1fdf16e5-145d-4c19-a318-fc6c10794b50.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6022-01ML - Milliliter0641-602214529626-4b70-42c6-a890-9b69073ec03a12013-02-13
0641-6022-25ML - Milliliter0641-60224387b354-0e9e-4478-9b06-72f87bf78c5812012-07-24

DailyMed Socrata Ingredients#

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 26 of 29 · 576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
FamotidineFAMOTIDINEA-S Medication Solutions74ff64f2-d882-411f-bac8-29dfa4cb4f102023-08-09Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Maximum Strength Acid ControllerFAMOTIDINEBETTER LIVING BRANDS LLC.f2c031b4-de86-3a8e-e053-2a95a90a21e02023-07-30WarningsExact identifier
unii: 5QZO15J2Z8
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FAMOTIDINEFAMOTIDINEBiocon Pharma Inc.ea7287a4-75e0-39d2-5b2e-b72b7cb386b92023-05-21Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FamotidineFAMOTIDINEMedical Purchasing Solutions, LLCbbeffa0a-2bc7-fea4-e053-2a95a90ac5112023-05-08Warnings, Adverse reactionsExact identifier
application number: ANDA075486
ndc (package): 71872-7235-1
ndc (product): 71872-7235
rxcui: 1743833
spl id: fb339cb7-08a5-d926-e053-6394a90a6c7f
spl set id: bbeffa0a-2bc7-fea4-e053-2a95a90ac511
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEMedical Purchasing Solutions, LLCb6214fc9-a274-ef45-e053-2a95a90ae43a2023-05-04Adverse reactionsExact identifier
rxcui: 1743833
unii: 5QZO15J2Z8
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FamotidineFAMOTIDINEBluePoint Laboratoriesbefd8d44-c6f7-eca2-e053-2995a90a714b2023-03-23WarningsExact identifier
unii: 5QZO15J2Z8
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
IBUPROFEN AND FAMOTIDINEIBUPROFEN AND FAMOTIDINEAscent Pharmaceuticals, Inc.03733e49-7db4-4d98-b363-d0d23686ec722023-03-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEProficient Rx LPfe21daca-ac48-4b46-9cb3-9a69af0c6a842023-03-01Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
FAMOTIDINEFAMOTIDINEZydus Pharmaceuticals USA Inc.a8010e10-68fd-455f-968f-d62a1c3e0ffd2022-12-02Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEFresenius Kabi USA, LLCaeb27cea-1ff7-4a6e-93f1-d4c4dac5faa72022-11-08Warnings, Adverse reactionsExact identifier
rxcui: 1743833
unii: 5QZO15J2Z8
SpectricETHYLICUM, KALI BROMATUM, ASPARTIC ACID, L-DOPA, SEROTONIN (HYDROCHLORIDE), CEREBRUM SUIS, PLACENTA TOTALIS SUIS, AGARICUS MUSCARIUS, BUFO RANA, HELLEBORUS NIGER, HYOSCYAMUS NIGER, OLIBANUM (BOSWELLIA SERRATA), STRAMONIUM, THUJA OCCIDENTALIS, HELIUM, NEON, CARCINOSIN, HYDROGENDeseret Biologicals, Inc3e534017-4a9f-42a2-bdfd-1e8c73c0515a2022-11-08WarningsExact identifier
unii: 30KYC7MIAI
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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