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 105 of 185 · 3,691 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Assorted Hand Sanitizer -Passion FruitALCOHOLShenzhen Lantern Scicence Co.,Ltd.38895b60-f5a8-880f-e063-6394a90aa7062025-06-27WarningsExact identifier
unii: 3K9958V90M
Smart Care Assorted Hand Sanitizer -HibiscusALCOHOLShenzhen Lantern Scicence Co.,Ltd.3889d467-b179-bac4-e063-6394a90a61562025-06-27WarningsExact identifier
unii: 3K9958V90M
Smart Care Assorted Hand Sanitize -Cucumber MelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.388a975c-b0b6-b80e-e063-6294a90a18142025-06-27WarningsExact identifier
unii: 3K9958V90M
Smart Care Assorted Hand Sanitizer -Sweet CitrusALCOHOLShenzhen Lantern Scicence Co.,Ltd.388abca3-12fb-449a-e063-6394a90aea982025-06-27WarningsExact identifier
unii: 3K9958V90M
InterSolPLATELET ADDITIVE 3Fenwal, Inc.17dec820-1b57-4ac9-82a8-419cab664a2f2025-06-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Smart Care Hand Sanitizer - Caramel HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.3874c203-2c8b-79b3-e063-6294a90aedfb2025-06-26WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer - Sweet CitrusALCOHOLShenzhen Lantern Scicence Co.,Ltd.38863865-9361-fd1a-e063-6394a90a84f42025-06-26WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer - Squishmallows PattyALCOHOLShenzhen Lantern Scicence Co.,Ltd.38613f78-8480-637d-e063-6394a90a4ef32025-06-25WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer - BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.38626ced-5644-9f82-e063-6294a90ac7a12025-06-25WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer - Pistachio BruleALCOHOLShenzhen Lantern Scicence Co.,Ltd.38715507-d881-d8b3-e063-6394a90ad3482025-06-25WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer - Juicy BerryALCOHOLShenzhen Lantern Scicence Co.,Ltd.3871ec77-de30-0c89-e063-6394a90a9e7a2025-06-25WarningsExact identifier
unii: 3K9958V90M
Meijer Hydrating Power Mist Hand Sanitizer- GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.384c26c8-7f2d-8c3a-e063-6394a90aa9082025-06-24WarningsExact identifier
unii: 3K9958V90M
microdot Hand Sanitizing WipeETHYL ALCOHOLCambridge Sensors USA, LLC3284ab00-a17d-d961-e063-6294a90af4ea2025-06-24WarningsExact identifier
unii: 3K9958V90M
Dehydrated AlcoholALCOHOLXGen Pharmaceuticals DJB, Inc.35a568f3-83cd-452e-e063-6394a90a8c1d2025-06-23Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Smart Care Barbie Peony Petals Scent HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.531e8a24-3bbb-4cc6-a63f-676e843df3d62025-06-23WarningsExact identifier
unii: 3K9958V90M
Smart Care CITRUS AND SUEDE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.bca6fafa-3d89-419f-89b0-988a331596422025-06-23WarningsExact identifier
unii: 3K9958V90M
Smart Care CITRUS AND SUEDE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.c2c1b567-3fe1-4dd0-b1fd-9c88f1f06a142025-06-20WarningsExact identifier
unii: 3K9958V90M
InstantFoam Complete PUREALCOHOLSC Johnson Professional USA Inc.22eaf210-ff25-4bec-a6d4-65c711d2917f2025-06-20WarningsExact identifier
unii: 3K9958V90M
Sweet Orange Bergamot and AloeETHYL ALCOHOLALO New York LLC31cecf1e-1d6b-0033-e063-6294a90a7b8e2025-06-18WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Brazilian Caramel ScentedALCOHOLFourstar Group USA, Inc.30aaedbb-ffb9-4d00-a763-d5444074deb22025-06-17WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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