argatroban (63323-526) | FunFoxMeds NDC

Drug Facts

Product Profile

Brand Name argatroban

Generic Name argatroban

Labeler fresenius kabi usa, llc

Dosage Form INJECTION, SOLUTION

Routes

INTRAVENOUS

Active Ingredients

argatroban 100 mg/mL

Manufacturer

Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-526

Product ID 63323-526_c5ad8f27-49b3-41a1-884f-4e07ffa86558

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA

Application Number NDA201811

Listing Expiration 2026-12-31

Marketing Start 2015-03-23

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 63323526

Hyphenated Format 63323-526

Supplemental Identifiers

RxCUI

308351

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 NDA201811 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

100 mg/mL

source: ndc

Packaging

16 HOW SUPPLIED/STORAGE AND HANDLING NDC 63323-526-03, 250 mg per 2.5 mL (100 mg per mL) single-dose vial, packaged individually. Storage Store the vial in original carton at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Protect from light (keep in outer carton). If the solution is cloudy, or if an insoluble precipitate is noted, the vial should be discarded. The container closure is not made with natural rubber latex.
PACKAGE LABEL - PRINCIPAL DISPLAY - Argatroban 2.5 mL Single Dose Vial Label Argatroban Injection 250 mg per 2.5 mL (100 mg per mL) For intravenous use only. Must be diluted prior to administration. Preservative free. Single Dose Vial Rx only Discard unused portion. PACKAGE LABEL - PRINCIPAL DISPLAY - Argatroban 2.5 mL Single Dose Vial Carton Panel Argatroban Injection 250 mg per 2.5 mL (100 mg per mL) For intravenous use only. Must be diluted prior to administration. Preservative free. Sterile, Nonpyrogenic. Discard unused portion. Packaged Individually. Rx only Single Dose Vial vial box

source: label

Packages (0)

No package records.

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": "c5ad8f27-49b3-41a1-884f-4e07ffa86558", "openfda": {"nui": ["N0000175980", "N0000175518", "N0000009963"], "unii": ["IY90U61Z3S"], "rxcui": ["308351"], "spl_set_id": ["e1cf0ad0-0b23-497e-9deb-3de3bf48be44"], "pharm_class_epc": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]"], "pharm_class_moa": ["Thrombin Inhibitors [MoA]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Argatroban", "product_id": "63323-526_c5ad8f27-49b3-41a1-884f-4e07ffa86558", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "63323-526", "generic_name": "Argatroban", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Argatroban", "active_ingredients": [{"name": "ARGATROBAN", "strength": "100 mg/mL"}], "application_number": "NDA201811", "marketing_category": "NDA", "marketing_start_date": "20150323", "listing_expiration_date": "20261231"}