FDA.reportPublic FDA data

NDC 68462-758-05 - 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
68462-758
Requested NDC
68462-758-05
Package NDCs from labels
68462-758-05, 68462-758-25
Manufacturer
GLENMARK PHARMACEUTICALS INC | GLAND PHARMA LIMITED
Effective date
2025-12-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Phytonadione - GLENMARK PHARMACEUTICALS INC | GLAND PHARMA LIMITEDGLENMARK PHARMACEUTICALS INC | GLAND PHARMA LIMITED2025-12-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-758-05Phytonadione1 mL in 1 AMPULEINJECTION, EMULSION12
68462-758-05Phytonadione5 in 1 TRAYINJECTION, EMULSION52
68462-758-25Phytonadione5 in 1 CARTONINJECTION, EMULSION52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-758PHYTONADIONE INJECTION, EMULSION [GLENMARK PHARMACEUTICALS INC]1Current NDC, 3 package rows20241220_60e5abd1-e2fa-4a5e-b25b-3ec6cfdeed14.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-758-05ML - Milliliter68462-758b578eb63-8a15-49f0-beb0-ca912cd87e9712025-02-10
68462-758-25ML - Milliliter68462-758bd22345f-03d9-4c82-965d-72a3bab4af8112025-02-10

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 19 · 380 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DextroseDEXTROSE MONOHYDRATEHenry Schein, Inc.8cf6943f-16e8-4521-863c-09bb0b55e2a92026-09-09Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DextroseDEXTROSE MONOHYDRATEREMEDYREPACK INC.b8b77421-d687-45aa-82f6-d49bce644c102026-08-31Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
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
PHYTONADIONEPHYTONADIONEHF Acquisition Co LLC, DBA HealthFirst5686f34b-446a-00ae-e063-6394a90a60292026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1670192
unii: A034SE7857
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLCdf18a603-ca12-4b26-83b5-9dd07b6453ab2026-08-18Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCbbc5b820-4973-11e2-a192-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCc29bdfa0-4976-11e2-939b-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLC515dcee0-3e34-11e2-a25f-0800200c9a662026-08-18Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Vitamin K1PHYTONADIONEHospira, Inc.e8808230-2c44-44c6-8cab-8f29b6b340512026-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1670192
unii: A034SE7857
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
unii: LKG8494WBH
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DextroseDEXTROSE MONOHYDRATEHospira, Inc.4ed365da-4e62-4329-c1b9-c197ab4fb6e12026-07-13Warnings, Adverse reactionsExact identifier
unii: LX22YL083G
Infant DextroseDEXTROSEHenry Schein, Inc.ce71d929-d11e-444c-bd45-e025d51720572026-07-13Warnings, Adverse reactionsExact identifier
unii: LX22YL083G

Reported adverse events (FAERS/openFDA)#

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