heparin sodium

Generic: heparin sodium

Labeler: hepalink usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name heparin sodium
Generic Name heparin sodium
Labeler hepalink usa inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

heparin sodium 10000 [USP'U]/mL

Manufacturer
Hepalink USA Inc.

Identifiers & Regulatory

Product NDC 81952-113
Product ID 81952-113_2e8e07a4-763e-79e5-e063-6394a90a7619
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203198
Listing Expiration 2026-12-31
Marketing Start 2014-06-12

Pharmacologic Class

Classes
anti-coagulant [epc] heparin [cs] unfractionated heparin [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81952113
Hyphenated Format 81952-113

Supplemental Identifiers

RxCUI
1361226 1361574 1361615 1362831 1658647
UPC
0381952113018 0381952115074 0381952116019 0381952112103 0381952116064 0381952112059 0381952114091 0381952113063 0381952113032 0381952114046 0381952112042 0381952112097 0381952113087 0381952112066 0381952111069
UNII
ZZ45AB24CA

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 heparin sodium (source: ndc)
Generic Name heparin sodium (source: ndc)
Application Number ANDA203198 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10000 [USP'U]/mL
source: ndc
Packaging
  • 25 VIAL, MULTI-DOSE in 1 CARTON (81952-113-06) / 1 mL in 1 VIAL, MULTI-DOSE (81952-113-01)
  • 25 VIAL, MULTI-DOSE in 1 CARTON (81952-113-08) / 5 mL in 1 VIAL, MULTI-DOSE (81952-113-03)
source: ndc

Packages (2)

81952-113-06 25 VIAL, MULTI-DOSE in 1 CARTON (81952-113-06) / 1 mL in 1 VIAL, MULTI-DOSE (81952-113-01) 81952-113-08 25 VIAL, MULTI-DOSE in 1 CARTON (81952-113-08) / 5 mL in 1 VIAL, MULTI-DOSE (81952-113-03)

Ingredients (1)

heparin sodium (10000 [USP'U]/mL)

Linked Drug Pages (1)

Heparin Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "2e8e07a4-763e-79e5-e063-6394a90a7619", "openfda": {"upc": ["0381952113018", "0381952115074", "0381952116019", "0381952112103", "0381952116064", "0381952112059", "0381952114091", "0381952113063", "0381952113032", "0381952114046", "0381952112042", "0381952112097", "0381952113087", "0381952112066", "0381952111069"], "unii": ["ZZ45AB24CA"], "rxcui": ["1361226", "1361574", "1361615", "1362831", "1658647"], "spl_set_id": ["c4c6bc1f-e0c7-fd0d-e053-2995a90abdef"], "manufacturer_name": ["Hepalink USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 CARTON (81952-113-06)  / 1 mL in 1 VIAL, MULTI-DOSE (81952-113-01)", "package_ndc": "81952-113-06", "marketing_start_date": "20140612"}, {"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 CARTON (81952-113-08)  / 5 mL in 1 VIAL, MULTI-DOSE (81952-113-03)", "package_ndc": "81952-113-08", "marketing_start_date": "20140612"}], "brand_name": "Heparin Sodium", "product_id": "81952-113_2e8e07a4-763e-79e5-e063-6394a90a7619", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anti-coagulant [EPC]", "Heparin [CS]", "Unfractionated Heparin [EPC]"], "product_ndc": "81952-113", "generic_name": "Heparin Sodium", "labeler_name": "Hepalink USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Heparin Sodium", "active_ingredients": [{"name": "HEPARIN SODIUM", "strength": "10000 [USP'U]/mL"}], "application_number": "ANDA203198", "marketing_category": "ANDA", "marketing_start_date": "20140612", "listing_expiration_date": "20261231"}