heparin sodium

Generic: heparin sodium

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name heparin sodium
Generic Name heparin sodium
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

heparin sodium 1000 [USP'U]/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-427
Product ID 68083-427_794ab494-666a-4e82-ba24-982189a20255
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205323
Listing Expiration 2026-12-31
Marketing Start 2019-11-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083427
Hyphenated Format 68083-427

Supplemental Identifiers

RxCUI
1361226 1361615
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 ANDA205323 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1000 [USP'U]/mL
source: ndc
Packaging
  • 25 VIAL, MULTI-DOSE in 1 CARTON (68083-427-25) / 10 mL in 1 VIAL, MULTI-DOSE (68083-427-01)
source: ndc

Packages (1)

68083-427-25 25 VIAL, MULTI-DOSE in 1 CARTON (68083-427-25) / 10 mL in 1 VIAL, MULTI-DOSE (68083-427-01)

Ingredients (1)

heparin sodium (1000 [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": "794ab494-666a-4e82-ba24-982189a20255", "openfda": {"unii": ["ZZ45AB24CA"], "rxcui": ["1361226", "1361615"], "spl_set_id": ["301b19bc-21c2-4a35-9d29-569b08d855c4"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 CARTON (68083-427-25)  / 10 mL in 1 VIAL, MULTI-DOSE (68083-427-01)", "package_ndc": "68083-427-25", "marketing_start_date": "20191118"}], "brand_name": "Heparin Sodium", "product_id": "68083-427_794ab494-666a-4e82-ba24-982189a20255", "dosage_form": "INJECTION", "pharm_class": ["Anti-coagulant [EPC]", "Heparin [CS]", "Unfractionated Heparin [EPC]"], "product_ndc": "68083-427", "generic_name": "Heparin Sodium", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Heparin Sodium", "active_ingredients": [{"name": "HEPARIN SODIUM", "strength": "1000 [USP'U]/mL"}], "application_number": "ANDA205323", "marketing_category": "ANDA", "marketing_start_date": "20191118", "listing_expiration_date": "20261231"}