argatroban

Generic: argatroban

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name argatroban
Generic Name argatroban
Labeler amneal pharmaceuticals llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

argatroban 100 mg/mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 70121-1037
Product ID 70121-1037_f7911ddf-f082-4900-9504-d45cc15861c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206698
Listing Expiration 2026-12-31
Marketing Start 2018-01-26

Pharmacologic Class

Established (EPC)
anti-coagulant [epc] direct thrombin inhibitor [epc]
Mechanism of Action
thrombin inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 701211037
Hyphenated Format 70121-1037

Supplemental Identifiers

RxCUI
308351
UPC
0370121103714
UNII
IY90U61Z3S
NUI
N0000175980 N0000175518 N0000009963

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name argatroban (source: ndc)
Generic Name argatroban (source: ndc)
Application Number ANDA206698 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (70121-1037-1) / 2.5 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

70121-1037-1 1 VIAL, GLASS in 1 CARTON (70121-1037-1) / 2.5 mL in 1 VIAL, GLASS

Ingredients (1)

argatroban (100 mg/mL)

Linked Drug Pages (1)

Argatroban ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "f7911ddf-f082-4900-9504-d45cc15861c0", "openfda": {"nui": ["N0000175980", "N0000175518", "N0000009963"], "upc": ["0370121103714"], "unii": ["IY90U61Z3S"], "rxcui": ["308351"], "spl_set_id": ["dedef330-555a-46b7-b1d6-0838b4cd9651"], "pharm_class_epc": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]"], "pharm_class_moa": ["Thrombin Inhibitors [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (70121-1037-1)  / 2.5 mL in 1 VIAL, GLASS", "package_ndc": "70121-1037-1", "marketing_start_date": "20180126"}], "brand_name": "Argatroban", "product_id": "70121-1037_f7911ddf-f082-4900-9504-d45cc15861c0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "70121-1037", "generic_name": "Argatroban", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Argatroban", "active_ingredients": [{"name": "ARGATROBAN", "strength": "100 mg/mL"}], "application_number": "ANDA206698", "marketing_category": "ANDA", "marketing_start_date": "20180126", "listing_expiration_date": "20261231"}