FDA.reportPublic FDA data

NDC 70700-331-24 - Phytonadione

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
70700-331
Requested NDC
70700-331-24
Package NDCs from labels
70700-331-24, 70700-331-25
Manufacturer
Xiromed LLC | Gland Pharma Limited
Effective date
2025-08-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Phytonadione - Xiromed LLC | Gland Pharma LimitedXiromed LLC | Gland Pharma Limited2025-08-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70700-331-24Phytonadione5 in 1 TRAYINJECTION, EMULSION52
70700-331-24Phytonadione1 mL in 1 AMPULEINJECTION, EMULSION12
70700-331-25Phytonadione5 in 1 CARTONINJECTION, EMULSION52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-331-24ML - Milliliter70700-33145333d92-862e-4edc-bdc5-15140611657a12025-09-12
70700-331-25ML - Milliliter70700-331bb340ae0-094c-4d5c-8f31-54b972222b4612025-09-12

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 8 of 19 · 379 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DextroseDEXTROSE MONOHYDRATEProPharma Distribution3eff8bcd-6a33-428f-e063-6394a90afa682025-09-17Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
PerikabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCc2eb5522-8572-45f4-869d-42f9fd251bb62025-09-15Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
PhytonadionePHYTONADIONEAlembic Pharmaceuticals Limited6ccb76ab-1549-4a47-a119-8059588ad83d2025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A034SE7857
PhytonadionePHYTONADIONEAlembic Pharmaceuticals Inc.b1e53422-c85d-4bb6-af4f-24934cc319b02025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A034SE7857
KabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCafeb4837-a759-4484-a76e-e04611c459e72025-09-11Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
PhytonadionePHYTONADIONECoupler LLC3e4f86c4-7e89-c864-e063-6394a90a59af2025-09-08Adverse reactionsExact identifier
unii: A034SE7857
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dextrose and Sodium ChlorideDEXTROSE AND SODIUM CHLORIDEBaxter Healthcare Companydcbf1907-1841-4afc-ab5d-a9893a2d72562025-08-26Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
PhytonadionePHYTONADIONEXiromed LLCa4b394e7-b766-824e-a8bf-f56808de76e12025-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA217386
ndc (package): 70700-331-24
ndc (package): 70700-331-25
ndc (product): 70700-331
ndc11 (package): 70700033124
rxcui: 1670192
spl id: 2151937d-2482-d1f1-fbb4-08df466c26a0
spl set id: a4b394e7-b766-824e-a8bf-f56808de76e1
unii: A034SE7857
Pediatric Infuvite Multiple VitaminsASCORBIC ACID, VITAMIN A PALMITATE, CHOLECALCIFEROL, THIAMINE HYDROCHLORIDE, RIBOFLAVIN-5 PHOSPHATE SODIUM, PYRIDOXINE HYDROCHLORIDE, NIACINAMIDE, DEXPANTHENOL, ALPHA-TOCOPHEROL ACETATE, VITAMIN K1, FOLIC ACID, BIOTIN, CYANOCOBALAMINSandoz Inc4ff223f7-e076-4e81-8151-5c06724fabd92025-08-18Warnings, Adverse reactionsExact identifier
unii: A034SE7857
DextroseDEXTROSE MONOHYDRATEBaxter Healthcare Companybfc4224a-2fc9-4137-b4c6-9d2d6d9484132025-07-30Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEProPharma Distribution3842a9c0-8b15-1c94-e063-6394a90ae1202025-07-18Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC0956bd7c-d46f-483a-bf2c-9e11c6111ebf2025-07-02Exact identifier
unii: LX22YL083G

Reported adverse events (FAERS/openFDA)#

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