FDA.reportPublic FDA data

NDC 69097-003-67 - 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
69097-003
Requested NDC
69097-003-67
Package NDCs from labels
69097-003-67, 69097-003-96
Manufacturer
Cipla USA Inc. | Cipla Limited | GLAND PHARMA LIMITED | DSM Nutritional Products AG Zweigniederlassung Werk Sisseln
Effective date
2025-01-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PhytonadioneCipla USA Inc. | Cipla Limited | GLAND PHARMA LIMITED | DSM Nutritional Products AG Zweigniederlassung Werk Sisseln2025-01-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-003-67Phytonadione0.5 mL in 1 SYRINGEINJECTION, EMULSION0.52
69097-003-96Phytonadione10 in 1 CARTONINJECTION, EMULSION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-003PHYTONADIONE INJECTION, EMULSION [CIPLA USA INC.]2Current NDC, 2 package rows20250115_4bc2de7b-6564-4d77-8a65-6be57b706093.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-003-67ML - Milliliter69097-0033608d6ea-bcea-4ba3-9211-6ca9cc15178012025-05-14
69097-003-96ML - Milliliter69097-0033a75814a-111c-4524-a0b1-363015554c0712025-05-14

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 15 of 19 · 376 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLMeijer Distribution, Inc.9feadde4-fbe5-0c9e-e053-2995a90a9b302023-12-22WarningsExact identifier
unii: 6DC9Q167V3
Meijer Ultra Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLMeijer Distribution, Inc.a0846e3e-687c-fd55-e053-2995a90a673e2023-12-22WarningsExact identifier
unii: 6DC9Q167V3
Walgreens Lubricant Eye Drops High Performance 15mL and twin packPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalgreen Company94ee8310-1c19-dfd4-e053-2a95a90a83562023-12-20WarningsExact identifier
unii: 6DC9Q167V3
Walgreens Lubricant Eye Drops Dry Eye 15mL and twin packPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalgreen Company94f6e1cd-073c-61ca-e053-2a95a90ae7252023-12-20WarningsExact identifier
unii: 6DC9Q167V3
Kroger High Performance Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLKrogerd2aa8963-1922-02f3-e053-2a95a90a7d932023-12-20WarningsExact identifier
unii: 6DC9Q167V3
Topcare Health Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTopco Assoc LLC9c6284f9-00bb-37b5-e053-2a95a90ae2ee2023-12-20WarningsExact identifier
unii: 6DC9Q167V3
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.db3a6c68-320b-46b0-83fa-6c29297a84a62023-12-15WarningsExact identifier
unii: 6DC9Q167V3
SystanePOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLAlcon Research Ltd14916d2c-a63d-491e-bd91-a61f300af38a2023-12-15WarningsExact identifier
unii: 6DC9Q167V3
PHYTONADIONEPHYTONADIONEBaxter Healthcare Corporation98fa1675-8af1-42c5-bbab-8b3632d52a0f2023-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A034SE7857
Systane LubricantPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.15bc06ec-f3dc-3180-ca1a-106769a770ea2023-12-15WarningsExact identifier
unii: 6DC9Q167V3
Systane ULTRAPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.a5c1c194-3db5-4f18-9cd1-97f7f84c3cff2023-12-15WarningsExact identifier
unii: 6DC9Q167V3
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.7eaa93ca-c843-4c89-921b-c76659410dce2023-12-14WarningsExact identifier
unii: 6DC9Q167V3
GenTeal Tears Gel DropsPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.84388a75-9d11-48ce-bf5a-88f0580d2d032023-12-14WarningsExact identifier
unii: 6DC9Q167V3
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
PhytonadionePHYTONADIONEExelan Pharmaceuticals, Inc.63771c95-d4f5-42eb-b591-4df146f18cb02023-11-01Adverse reactionsExact identifier
unii: A034SE7857
PhytonadionePHYTONADIONECipla USA., Inc.7dd1f275-94d3-45d2-a4d0-696ce60a2a9b2023-11-01Adverse reactionsExact identifier
unii: A034SE7857
HPYL PLUSANGELICA ARCHANGELICA, GERANIUM MACULATUM, HYDRASTIS CANADENSIS, SINAPIS NIGRA, SYMPHYTUM OFFICINALE, RATANHIA, ACETICUM ACIDUM, CARBOLICUM ACIDUM, ORNITHOGALUM UMBELLATUM, ABIES CANADENSIS, ANACARDIUM ORIENTALE, BISMUTHUM SUBNITRICUM, CONDURANGO, GRAPHITES, IRIS VERSICOLOR, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MEZEREUM, EUPHORBIUM OFFICINARUM, NUX VOMICADeseret Biologicals, Inc.c90278bf-b08a-4c79-86c0-dafd3b7756c62023-10-12WarningsExact identifier
unii: Q40Q9N063P
BHI MigraineACETIC ACID, ARANEUS DIADEMATUS, ASAFETIDA, BRYONIA ALBA WHOLE, TRIBASIC CALCIUM PHOSPHATE, ACTIVATED CHARCOAL, CINCHONA OFFICINALIS BARK, MARSDENIA CONDURANGO BARK, TUBOCURARINE CHLORIDE, KALMIA LATIFOLIA LEAF, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, PHOSPHORIC ACID, PULSATILLA VULGARIS, CLAVICEPS PURPUREA SCLEROTIUM, AND SILICON DIOXIDEMediNatura Inc11cad8ba-6914-420e-bab0-4ca37d33f2e62023-09-28WarningsExact identifier
unii: Q40Q9N063P
Pancreas SarcodeCHAMOMILLA, GLYCYRRHIZA GLABRA, SYZYGIUM JAMBOLANUM, VACCINIUM MYRTILLUS, ACETICUM ACIDUM, CONDURANGO, PHASEOLUS, SARSAPARILLA (SMILAX REGELII), PANCREAS SUIS, URICUM ACIDUMNutritional Specialties, Inc.56a6dbc1-3a6b-444f-8082-1999a64e529c2023-09-25WarningsExact identifier
unii: Q40Q9N063P
Vitalipid NVITAMIN A PALMITATE, ERGOCALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PHYTONADIONEFresenius Kabi USA, LLC704119cc-d2ad-408a-b213-fe232f7fe2ba2023-09-07Exact identifier
unii: A034SE7857

Reported adverse events (FAERS/openFDA)#

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