heparin sodium

Generic: heparin sodium

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name heparin sodium
Generic Name heparin sodium
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

heparin sodium 5000 [USP'U]/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-403
Product ID 71288-403_505f018d-608d-4dd4-b7b9-640b25b0fc44
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211007
Listing Expiration 2026-12-31
Marketing Start 2019-06-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288403
Hyphenated Format 71288-403

Supplemental Identifiers

RxCUI
1361226 1361615 1362831 1658637 1658659 1659263
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 ANDA211007 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 5000 [USP'U]/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-403-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-403-01)
  • 25 VIAL, MULTI-DOSE in 1 CARTON (71288-403-11) / 10 mL in 1 VIAL, MULTI-DOSE (71288-403-10)
source: ndc

Packages (2)

71288-403-02 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-403-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-403-01) 71288-403-11 25 VIAL, MULTI-DOSE in 1 CARTON (71288-403-11) / 10 mL in 1 VIAL, MULTI-DOSE (71288-403-10)

Ingredients (1)

heparin sodium (5000 [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": "505f018d-608d-4dd4-b7b9-640b25b0fc44", "openfda": {"unii": ["ZZ45AB24CA"], "rxcui": ["1361226", "1361615", "1362831", "1658637", "1658659", "1659263"], "spl_set_id": ["02fb700d-a28c-4d45-b78d-382dc0d5986c"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (71288-403-02)  / 1 mL in 1 VIAL, SINGLE-DOSE (71288-403-01)", "package_ndc": "71288-403-02", "marketing_start_date": "20190615"}, {"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 CARTON (71288-403-11)  / 10 mL in 1 VIAL, MULTI-DOSE (71288-403-10)", "package_ndc": "71288-403-11", "marketing_start_date": "20190615"}], "brand_name": "Heparin Sodium", "product_id": "71288-403_505f018d-608d-4dd4-b7b9-640b25b0fc44", "dosage_form": "INJECTION", "pharm_class": ["Anti-coagulant [EPC]", "Heparin [CS]", "Unfractionated Heparin [EPC]"], "product_ndc": "71288-403", "generic_name": "Heparin Sodium", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Heparin Sodium", "active_ingredients": [{"name": "HEPARIN SODIUM", "strength": "5000 [USP'U]/mL"}], "application_number": "ANDA211007", "marketing_category": "ANDA", "marketing_start_date": "20190615", "listing_expiration_date": "20261231"}