FDA.reportPublic FDA data

NDC 83301-0062-01 - 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
83301-0062
Requested NDC
83301-0062-01
Package NDCs from labels
83301-0062-1, 83301-0062-01
Manufacturer
Mullan Pharmaceutical Inc. | Gland Pharma Limited
Effective date
2026-06-15
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 Limited2026-06-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83301-0062-1Argatroban50 mL in 1 VIAL, SINGLE-DOSEINJECTION501
83301-0062-1Argatroban1 in 1 CARTONINJECTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83301-0062-1ML - Milliliter83301-006277c1ad7b-1c6d-4d46-9c7c-113c0e1d69b612026-02-05

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 146 of 184 · 3,678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Symmetry Foaming Hand SanitizerALCOHOLBuckeye International, Inc.bcab4842-50ff-4c7f-8b85-0126f4b585b02024-07-23Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Altra Hand Sanitizer with Aloe and Vitamin EALCOHOLBuckeye International, Inc.a2974445-eaa3-d9f0-e053-2995a90a78fc2024-07-23WarningsExact identifier
unii: 3K9958V90M
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC83994d0c-8484-4505-abb5-8a384ed122882024-07-22Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
LAVENDER SCENTED HAND SANITIZER PENALCOHOLFourstar Group USA, Inc.5c27f212-4010-44de-9e9d-758ffdfcc5c12024-07-18WarningsExact identifier
unii: 3K9958V90M
CITRUS SCENTED HAND SANITIZER PENALCOHOLFourstar Group USA, Incb3c59433-a4cd-42cb-9492-fcdc19ca765c2024-07-18WarningsExact identifier
unii: 3K9958V90M
COCONUT SCENTED HAND SANITIZER PENALCOHOLFourstar Group USA, Inc.2fa53710-c084-48e0-8300-511d0d93a88d2024-07-18WarningsExact identifier
unii: 3K9958V90M
sodium chlorideSODIUM CHLORIDEBecton Dickinson and Company8df7dcf6-8714-6caf-e053-2995a90ab8cc2024-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
b.pure Hand Sanitizer Lemon ScentedALCOHOLFOURSTAR GROUP USA, INC.bc35f9ec-e453-4994-91ae-2294d058e45d2024-07-12WarningsExact identifier
unii: 3K9958V90M
b.pure Hand Sanitizer Watermelon ScentedALCOHOLFOURSTAR GROUP USA, INC.e0ed1b57-2d7e-4e63-96f5-dbbb2aef26df2024-07-12WarningsExact identifier
unii: 3K9958V90M
b.pure Hand Sanitizer Green Apple ScentedALCOHOLFOURSTAR GROUP USA, INC.7c870d8f-c298-4469-b6d1-f318f6adfd262024-07-12WarningsExact identifier
unii: 3K9958V90M
Ecolab FaciliproALCOHOLEcolab Inc.87aa66da-bbc7-4d02-851b-63c19e68578a2024-07-12WarningsExact identifier
unii: 3K9958V90M
Antiseptic Hand SanitizerETHYL ALCOHOLInnovation Specialties Incb80b88e1-e35c-47de-89ee-314d6054f4ce2024-07-10WarningsExact identifier
unii: 3K9958V90M
ANTISEPTIC HAND SANITIZERETHYL ALCOHOLInnovation Specialties Inc89af8a07-49cd-4b51-9ca7-016f849d7b702024-07-10WarningsExact identifier
unii: 3K9958V90M
5253 hand sanitizerETHYL ALCOHOLInnovation Specialties3ef15fec-bb7a-424a-a361-88a8f9503b5f2024-07-10WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerETHYL ALCOHOLInnovation Specialties Inc9bef34b7-fdd0-41ee-a140-ea82552aab472024-07-10WarningsExact identifier
unii: 3K9958V90M
Antiseptic Hand SanitizerETHYL ALCOHOLInnovation Specialties Inc10a9ea3c-f2a5-4b10-a9a0-12b95cb0f90a2024-07-10WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerETHYL ALCOHOLInnovation Specialties Inc7824f5c7-3650-490f-92cd-46c8ec32d7be2024-07-10WarningsExact identifier
unii: 3K9958V90M
Antiseptic Hand SanitizerETHYL ALCOHOLInnovation Specialties Inc5849d19f-5761-4500-9596-e705b78f14ae2024-07-10WarningsExact identifier
unii: 3K9958V90M
5406 hand sanitizerETHYL ALCOHOLInnovation Specialties8d83b133-1240-4ec8-9fca-e4cbb84f6caf2024-07-10WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLInnovation Specialties Incb2eee632-5a1d-4df5-99c8-8ceb3d644c942024-07-10WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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