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 7 of 19 · 376 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
PHYTONADIONEPHYTONADIONEHenry Schein, Inc.1cf90be3-a744-4db5-999d-a84c673723042025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: A034SE7857
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PHYTONADIONEPHYTONADIONEHenry Schein, Inc.0d971993-466c-46dd-bdd6-2e300173621e2025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 727625
unii: A034SE7857
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Systane Complete PFPROPYLENE GLYCOL EMULSIONAlcon Laboratories, Inc.798ffdde-1dba-4a3f-a0b6-937f9e958cca2025-11-03WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Normosol-R and DextroseDEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.ead1fca3-eff4-478f-8a8f-67510f80151a2025-10-30Warnings, Adverse reactionsExact identifier
unii: NVG71ZZ7P0
Normosol-RSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.0e089a44-0cee-4804-8f6f-8508508ddb5c2025-10-30Warnings, Adverse reactionsExact identifier
unii: NVG71ZZ7P0
Normosol-RSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEICU Medical Inc.189b8ac6-e346-454f-b501-7645590ca4f82025-10-29Warnings, Adverse reactionsExact identifier
unii: NVG71ZZ7P0
SKIN TAG REMOVERSALICYLIC ACIDShenzhen Yaozhihong Technology Co., Ltd.4246d4d5-9955-ba5a-e063-6394a90a84482025-10-29WarningsExact identifier
unii: Q40Q9N063P
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Advanced Eye Relief Dry Eye RejuvenationGLYCERIN PROPYLENE GLYCOLBausch & Lomb Incorporated027969ee-64e4-4b08-bab7-c4cc8ed22f5f2025-10-23WarningsExact identifier
unii: 6DC9Q167V3
phytonadionePHYTONADIONEAmneal Pharmaceuticals LLC2ce1dd90-11ad-4f74-af16-45b7e59f05da2025-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 727625
unii: A034SE7857
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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