FDA.reportPublic FDA data

NDC 60219-3955-03 - Fosfomycin Tromethamine

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
60219-3955
Requested NDC
60219-3955-03
Package NDCs from labels
60219-3955-3, 60219-3955-1, 60219-3955-03
Manufacturer
Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals Private Limited
Effective date
2024-04-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ORANGE - Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals Private LimitedAmneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals Private Limited2024-04-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60219-3955-1Fosfomycin Tromethamine1 in 1 CARTONGRANULE, FOR SOLUTION14
60219-3955-3Fosfomycin Tromethamine1 in 1 PACKETGRANULE, FOR SOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-3955FOSFOMYCIN TROMETHAMINE GRANULE, FOR SOLUTION [AMNEAL PHARMACEUTICALS NY LLC]4Current NDC, 2 package rows20240403_aacd04a4-f2d5-45a2-b9e7-0e92244a5880.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-3955-1EA - Each60219-3955123120ec-93d9-4816-a9b7-613b1b58dbd512025-05-14
60219-3955-3EA - Each60219-39554e62e24c-15cb-42bb-a414-62b49198f3fa12025-05-14

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 4 · 71 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: C151H8M554
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: C151H8M554
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.4a8be3aa-9bd9-4bb1-af98-a940c13b2bd02026-04-10WarningsExact identifier
unii: C151H8M554
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.214eb19a-e7a2-421c-9f34-724ce430185c2026-04-10WarningsExact identifier
unii: C151H8M554
Fosfomycin TromethamineFOSFOMYCIN TROMETHAMINEAucta Pharmaceuticals, Inc.4f206750-8126-99a3-e063-6294a90ade4c2026-04-09Warnings, Adverse reactionsExact identifier
rxcui: 808917
unii: 7FXW6U30GY
Drop20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Pick Enterprises Corpbaa96813-dc95-472e-a834-880a0cd484a72026-03-13WarningsExact identifier
unii: C151H8M554
Appetrol 20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Carbalor LLCd66234a3-2477-42be-8f7b-283e3a5f87ed2026-03-12WarningsExact identifier
unii: C151H8M554
Allergen IPOTASSIUM GLUCONATE, GLANDULA SUPRARENALIS BOVINE, HEPAR BOVINE, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PEANUT, BLACK WALNUT, ENGLISH WALNUT, AMYGDALA AMARA, CASHEW, COCONUT, PECAN, BRAZIL NUT, TOMATO, SOLANUM TUBEROSUM, PIPER NIGRUM, EGGPLANT (SOLANUM MELONGENA), RAPE SEED OIL, LINUM USITATISSIMUM, SESAME SEED, CHEESE (STILTON), LAC VACCINUM, BEEF, LAMB, PORK, CHICKEN, EGG (WHOLE), PHASEOLUS, ALLIUM CEPA, APPLE, WHEAT, BANANA, STRAWBERRY, COD (GADUS MORHUA), TUNA (THUNNUS THYNNUS),BioActive Nutritional25e10444-a2cc-4f74-bf38-9852c273e5ca2026-03-06WarningsExact identifier
unii: 5EVU04N5QU
Aquavit 1AQUAVIT 1Uriel Pharmacy Inc.2354fcfc-05a2-444a-ace4-b3df614131572026-02-02WarningsExact identifier
unii: KH3E3096OO
Artificial Sweetener Detox 6034ARTIFICIAL SWEETENER DETOXProfessional Complementary Health Formulas38f2ae0b-2b1f-4b49-934d-fe1556f84d932026-01-08WarningsExact identifier
unii: FST467XS7D
Anti-Smoking II Drops 2008ANTI-SMOKING II DROPSProfessional Complementary Health Formulas8e64a0eb-4673-42e3-8387-7248d38557872026-01-08WarningsExact identifier
unii: C151H8M554
Substance Abuse Drops 2063SUBSTANCE ABUSE DROPSProfessional Complementary Health Formulas61f8263d-6f72-442f-a09e-57daf7226cc72026-01-08WarningsExact identifier
unii: C151H8M554
Immune System Stimulator Drops 2033IMMUNE SYSTEM STIMULATOR DROPSProfessional Complementary Health Formulasf4595c63-1c9c-48a6-a13a-3659991f455b2026-01-08WarningsExact identifier
unii: FST467XS7D
Anti-Smoking I Drops 2007ANTI-SMOKING I DROPSProfessional Complementary Health Formulas1c6b5b98-971d-442a-b9eb-37f65409a5212026-01-08WarningsExact identifier
unii: C151H8M554
Glucose Drops 2031GLUCOSE DROPSProfessional Complementary Health Formulas21de3b86-be2b-4f71-9384-78ebc42ec0872026-01-08WarningsExact identifier
unii: C151H8M554
Multi Food AntigensARSENICUM ALBUM, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), ALLIUM CEPA, ALLIUM SATIVUM, ALMOND, APIUM GRAVEOLENS, BETA VULGARIS, BRASSICA OLERACEA VAR. ITALICA, BRAZIL, CACAO, CAPSICUM ANNUUM, CASHEW, CICER ARIETINUM, CITRUS LIMONUM, COCONUT, COFFEA TOSTA, COLLAGEN, CORN, CUCUMIS SATIVUS, ENGLISH WALNUT, GLYCINE MAX, HEART (BOVINE), HEART (SUIS), LAC VACCINUM, LACTUCA SATIVA, LYCOPERSICUM ESCULENTUM, ORANGE, OXALICUM ACIDUM, PEANUT, PECAN, PHASEOLUS, PHASEOLUS VULGARIS, RAPHANUS SATIVUS, SESAME,Energique, Inc.a289e8a7-1188-43be-b34b-fe6d5ee09d1c2026-01-06WarningsExact identifier
unii: 5EVU04N5QU
Fosfomycin TromethamineFOSFOMYCIN TROMETHAMINEPrecision Dose, Inc.f44b79d0-a789-46cb-ab70-7eb33a7debaf2025-12-23Warnings, Adverse reactionsExact identifier
rxcui: 808917
unii: 7FXW6U30GY
Fosfomycin TromethamineFOSFOMYCIN TROMETHAMINEAscend Laboratories, LLC48e352bc-52ea-4778-905a-60ef38a5c18a2025-12-17Warnings, Adverse reactionsExact identifier
rxcui: 808917
unii: 7FXW6U30GY
Histamine BalancerALLIUM CEPA, GALPHIMIA GLAUCA, SABADILLA, APIS MELLIFICA, ESTRADIOL, KALI SULPHURICUM, GLANDULA SUPRARENALIS (BOVINE), HEPAR (BOVINE), INTESTINE (SUIS), STOMACH (SUIS), HYPOTHALAMUS SUIS, LYMPH NODE (SUIS), AMBROSIA ARTEMISIAEFOLIA, CARBO VEGETABILIS, PEANUT, BLACK WALNUT, ENGLISH WALNUT, AMYGDALA AMARA, CASHEW, COCONUT, PECAN, BRAZIL NUT, TOMATO, SOLANUM TUBEROSUM, PIPER NIGRUM, EGGPLANT, RAPE SEED OIL, LINUM USITATISSIMUM, SESAME SEED, CHEESE (STILTON), LAC VACCINUM, BEEF, LAMB, PORK, CHICKEN, EGG,Nutritional Specialties, Inc.109b48f9-3588-49f0-ba02-397e09a477d12025-11-19WarningsExact identifier
unii: 5EVU04N5QU

Reported adverse events (FAERS/openFDA)#

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