FDA.reportPublic FDA data

NDC 51662-1375-01 - 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
51662-1375
Requested NDC
51662-1375-01
Package NDCs from labels
51662-1375-1, 51662-1375-2, 51662-1375-01
Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Effective date
2022-10-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FAMOTIDINE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2022-10-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1375-1FAMOTIDINE2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION23
51662-1375-2FAMOTIDINE1 in 1 POUCHINJECTION, SOLUTION13
51662-1375-2FAMOTIDINE2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1375FAMOTIDINE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]3Current NDC, Legacy NDC, 3 package rows20221002_9948991d-9405-c7c8-e053-2995a90a60ca.zip

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 18 of 20 · 388 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
FAMOTIDINEFAMOTIDINEBiocon Pharma Inc.ea7287a4-75e0-39d2-5b2e-b72b7cb386b92023-05-21Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEMedical Purchasing Solutions, LLCbbeffa0a-2bc7-fea4-e053-2a95a90ac5112023-05-08Warnings, Adverse reactionsExact identifier
rxcui: 1743833
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEMedical Purchasing Solutions, LLCb6214fc9-a274-ef45-e053-2a95a90ae43a2023-05-04Adverse reactionsExact identifier
rxcui: 1743833
unii: 5QZO15J2Z8
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
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
application number: ANDA075813
ndc (product): 63323-739
rxcui: 1743833
spl id: 7411dc23-e297-42cb-b491-b90d70c841a3
spl set id: aeb27cea-1ff7-4a6e-93f1-d4c4dac5faa7
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
FamotidineFAMOTIDINEFresenius Kabi USA, LLC5995d726-f3f8-4c2d-af19-1b12e3f769c62022-10-20Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
famotidineFAMOTIDINECamber Consumer Care Incebe3ca30-df25-4c56-8935-414a3431b5b92022-10-11WarningsExact identifier
unii: 5QZO15J2Z8
topcare acid reducerFAMOTIDINETopco Associates LLC7824fdab-cdd5-457d-9b14-b82b19ea95292022-10-03WarningsExact identifier
unii: 5QZO15J2Z8
FAMOTIDINEFAMOTIDINEHF Acquisition Co LLC, DBA HealthFirst9948991d-9405-c7c8-e053-2995a90a60ca2022-10-01Adverse reactionsExact identifier
application number: ANDA075813
ndc (package): 51662-1375-2
ndc (package): 51662-1375-1
ndc (product): 51662-1375
ndc11 (package): 51662137501
rxcui: 1743833
spl id: e9fd11b6-5cbd-ba83-e053-2a95a90a42af
spl set id: 9948991d-9405-c7c8-e053-2995a90a60ca
unii: 5QZO15J2Z8
famotidineFAMOTIDINENavinta LLC0f34a3be-7554-4040-b808-5ba8bf064abc2022-09-17Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
injoy heartburn reliefFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEL. Perrigo Companyaca1b9e5-a35e-4eef-b55a-4189cd1b2a022022-09-07WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEProficient Rx LPf32d0929-de22-4bec-9e24-bb549cf2679f2022-09-01Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Zantac 360 2 per blister 6 blistersFAMOTIDINEJC World Bell Wholesale Co., Inc.fd61a2d6-5c8a-4e7a-8b19-37406b90f7782022-08-15WarningsExact identifier
unii: 5QZO15J2Z8

Reported adverse events (FAERS/openFDA)#

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