FDA.reportPublic FDA data

NDC 63323-738-04 - 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
63323-738
Requested NDC
63323-738-04
Package NDCs from labels
63323-738-03, 63323-738-09, 63323-738-06, 63323-738-20, 63323-738-04
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2022-10-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Famotidine - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2022-10-20HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-738-03Famotidine4 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION46
63323-738-06Famotidine20 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION206
63323-738-09Famotidine10 in 1 TRAYINJECTION, SOLUTION106
63323-738-20Famotidine10 in 1 TRAYINJECTION, SOLUTION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-738FAMOTIDINE (FAMOTIDINE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]6Current NDC, Legacy NDC, 4 package rows20221027_5995d726-f3f8-4c2d-af19-1b12e3f769c6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-738-04ML - Milliliter63323-738c72698f4-3e89-481a-9915-d97fcc1d0c2612012-07-24
63323-738-06ML - Milliliter63323-738ebc9ffe6-5e6d-4cca-8741-aedc7644655912021-11-09
63323-738-09ML - Milliliter63323-7387490ccad-99a7-45f4-8296-23639022d1a512013-02-13
63323-738-20ML - Milliliter63323-738f81fc1c0-2897-4dc8-a28b-ce54469f36da12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
ASPARTIC ACIDINACTIVE INGREDIENT30KYC7MIAIFAMOTIDINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHFAMOTIDINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AFAMOTIDINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1

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 29 · 576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINEREMEDYREPACK INC.669fbd46-cae5-4477-884e-8eca893d2e052026-09-09Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
COMPLETE ACID REDUCERFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDb023cd92-eabb-474b-9b5a-4b46cf48256b2026-09-08WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEAurohealth LLC5b161f25-c578-4ff4-a931-ff3a1e681c502026-09-04WarningsExact identifier
unii: 5QZO15J2Z8
ACID REDUCERFAMOTIDINEAmazon.com Services LLCd5823283-aa97-451e-ba0d-69f0e79c85142026-08-31WarningsExact identifier
unii: 5QZO15J2Z8
FAMOTIDINEFAMOTIDINEREMEDYREPACK INC.9c5dce17-1865-4aa6-89f6-24dd55b5f06c2026-08-27Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Pepcid Complete Dual Action Berry FlavorFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEJones Healthcare Group - Packaging Services, Incfff07b68-02ca-438e-8d53-5b4edf5eefc52026-08-25WarningsExact identifier
unii: 5QZO15J2Z8
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.599642c8-51cd-4220-e063-6394a90a5e202026-08-24Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
0.9% Benzyl Alcohol Solution (Laboratory Use Only)0.9% BENZYL ALCOHOL SOLUTION (LABORATORY USE ONLY)Guangzhou Huanmei Cosmetics Co., Ltd5976bde6-0999-ffc4-e063-6394a90aadcf2026-08-20WarningsExact identifier
unii: LKG8494WBH
FamotidineFAMOTIDINEMajor Pharmaceuticals3e6d167f-91e4-4122-911d-d3da66386f442026-08-20Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
TrophAmineISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, AND TAURINEB. Braun Medical Inc.cb6d23ff-3ec5-445a-acbe-f88fd57949bf2026-08-19Warnings, Adverse reactionsExact identifier
unii: 30KYC7MIAI
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
FamotidineFAMOTIDINEPreferred Pharmaceuticals Inc.cd95271c-cf39-47fb-97a6-f6ee1e619e4a2026-08-12Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
heartburn preventionFAMOTIDINEKroger Companyc97851ef-7b49-4f6c-b165-147555db101a2026-08-11WarningsExact identifier
unii: 5QZO15J2Z8
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ACID REDUCERFAMOTIDINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf347f870-1da4-4a77-8c20-63b703d240712026-08-05WarningsExact identifier
unii: 5QZO15J2Z8
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEDoc Rx9f5de6af-e555-4efd-a3ed-b72c34c051b62026-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FAMOTIDINEFAMOTIDINEPD-Rx Pharmaceuticals, Inc.a0f38398-4d34-4ecc-8a6a-37732adaaad32026-07-30Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8

Reported adverse events (FAERS/openFDA)#

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