argatroban

Generic: argatroban

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name argatroban
Generic Name argatroban
Labeler accord healthcare inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

argatroban 1 mg/mL

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-430
Product ID 16729-430_23a830f8-e98e-81b2-e063-6394a90ad937
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212035
Listing Expiration 2026-12-31
Marketing Start 2021-10-07

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 16729430
Hyphenated Format 16729-430

Supplemental Identifiers

RxCUI
1804735
UPC
0316729430111
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 NDA212035 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (16729-430-11) / 50 mL in 1 VIAL, SINGLE-USE
  • 10 VIAL, SINGLE-USE in 1 CARTON (16729-430-43) / 50 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (2)

16729-430-11 1 VIAL, SINGLE-USE in 1 CARTON (16729-430-11) / 50 mL in 1 VIAL, SINGLE-USE 16729-430-43 10 VIAL, SINGLE-USE in 1 CARTON (16729-430-43) / 50 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

argatroban (1 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": "23a830f8-e98e-81b2-e063-6394a90ad937", "openfda": {"nui": ["N0000175980", "N0000175518", "N0000009963"], "upc": ["0316729430111"], "unii": ["IY90U61Z3S"], "rxcui": ["1804735"], "spl_set_id": ["46cdf9e6-839c-49c8-9ee1-c30cfdd9368d"], "pharm_class_epc": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]"], "pharm_class_moa": ["Thrombin Inhibitors [MoA]"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (16729-430-11)  / 50 mL in 1 VIAL, SINGLE-USE", "package_ndc": "16729-430-11", "marketing_start_date": "20211007"}, {"sample": false, "description": "10 VIAL, SINGLE-USE in 1 CARTON (16729-430-43)  / 50 mL in 1 VIAL, SINGLE-USE", "package_ndc": "16729-430-43", "marketing_start_date": "20211007"}], "brand_name": "ARGATROBAN", "product_id": "16729-430_23a830f8-e98e-81b2-e063-6394a90ad937", "dosage_form": "INJECTION", "pharm_class": ["Anti-coagulant [EPC]", "Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "16729-430", "generic_name": "Argatroban", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ARGATROBAN", "active_ingredients": [{"name": "ARGATROBAN", "strength": "1 mg/mL"}], "application_number": "NDA212035", "marketing_category": "NDA", "marketing_start_date": "20211007", "listing_expiration_date": "20261231"}