FDA.reportPublic FDA data

NDC 83301-0500-01 - Argatroban

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
83301-0500
Requested NDC
83301-0500-01
Package NDCs from labels
83301-0500-1, 83301-0500-01
Manufacturer
Mullan Pharmaceutical Inc. | Gland Pharma Limited
Effective date
2026-06-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Argatroban - Mullan Pharmaceutical Inc. | Gland Pharma LimitedMullan Pharmaceutical Inc. | Gland Pharma Limited2026-06-16HUMAN PRESCRIPTION DRUG LABEL

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 125 of 185 · 3,691 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AM-11ARNICA MONTANA, SODIUM CHLORIDE, AND APIS MELLIFERADNA Labs, Inc.c072811b-6259-4b22-b364-50369dc68fb02025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-13CEANOTHUS AMERICANUS LEAF, URTICA URENS, SODIUM CHLORIDE, LACHESIS MUTA WHOLE, CINCHONA OFFICINALIS BARK, LYCOPODIUM CLAVATUM WHOLE, FERRIC CHLORIDE HEXAHYDRATE, AND SUS SCROFA SPLEENDNA Labs, Inc.146c5465-bcd9-4057-8975-dc1088b9971b2025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-10SODIUM CHLORIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, SEPIA OFFICINALIS JUICE, IODINE, LYCOPODIUM CLAVATUM WHOLE, AND BOS TAURUS PITUITARY GLAND, POSTERIORDNA Labs, Inc.264d8093-70f3-43a5-bfc4-b719bb3e45e62025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-16MGO ENERGIZERDNA Labs, Inc.8292b900-86c1-47ea-81da-b587439c76642025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-21CALCIUM FLUORIDE, SILICON DIOXIDE, EUPHRASIA STRICTA, RUTA GRAVEOLENS WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, PHYSOSTIGMA VENENOSUM WHOLE, ANEMONE PULSATILLA, SODIUM CHLORIDE, AND SUS SCROFA EYEDNA Labs, Inc.89967941-c4ee-4598-a66d-8a93d69a4d652025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-14FUCUS VESICULOSUS, SODIUM CHLORIDE, LYCOPUS VIRGINICUS, SPONGIA OFFICINALIS SKELETON, ROASTED, POTASSIUM IODIDE, CALCIUM IODIDE, THYROID, UNSPECIFIED, BOS TAURUS ADRENAL GLAND, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS THYMUS, AND SUS SCROFA SPLEENDNA Labs, Inc.3d64739c-5d61-4e88-8612-d5f6994f1c3c2025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-24METABOLINDNA Labs, Inc.559fca2b-1093-4bdf-be70-c453f87002c32025-01-09WarningsExact identifier
unii: 451W47IQ8X
Hand RecoveryALCOHOLDerma Glove074a760f-9031-40c1-9867-95ef0345418d2025-01-08WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLTempo Industries, Inc.af9a0d53-0d4a-6dc7-e053-2a95a90acc1c2025-01-08WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLTempo Industries, Inc.af9a678b-488a-7045-e053-2995a90a401c2025-01-08WarningsExact identifier
unii: 3K9958V90M
BODYOGRAPHYPRO ANTI-BACTERIAL SANITIZINGETHYL ALCOHOLRobanda International, Inc.ebec43d4-4676-40f9-b989-5381f4a737c82025-01-08WarningsExact identifier
unii: 3K9958V90M
Dr. TalbotsETHYL ALCOHOLTalbots Pharmaceuticals Family Products, LLC.a6a94205-a9ff-7709-e053-2995a90a066b2025-01-08WarningsExact identifier
unii: 3K9958V90M
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst8dfb05c0-77e8-2fa1-e053-2a95a90a3d332025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst998a2a47-5c79-2efd-e053-2995a90a8fac2025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst7da788fc-3481-527f-e053-2a91aa0af6ac2025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
PentaCleanse Alcohol WipesALCOHOLPrestige Care Pharmacy Ince41a3e03-af01-5280-e053-2a95a90a8afc2025-01-08WarningsExact identifier
unii: 3K9958V90M
Gel Antiseptico DermowipeGEL ANTISEPTICO A BASE DE ALCOHOL ETILICOKey Qumica S.A. de C.V.15620afc-d6ae-0f34-e063-6294a90a8ad22025-01-07WarningsExact identifier
unii: 3K9958V90M
Sipa hand sanitizer with MoisturizersINSTANT HAND SANITIZERTourel (Changsha)Hotel Supplies Co.,Ltdfcbad83b-b8aa-a780-e053-6294a90a58ab2025-01-07WarningsExact identifier
unii: 3K9958V90M
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBECTON DICKINSON AND COMPANYc1d0f42e-3494-4217-8f86-e9f34d930e822025-01-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Instant Hand SanitizerALCOHOLWater-Jel Technologies54e62104-8076-41db-afe5-6dc5c3563acc2025-01-06WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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