heparin sodium

Generic: heparin sodium

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name heparin sodium
Generic Name heparin sodium
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

heparin sodium 1000 [USP'U]/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-540
Product ID 63323-540_df982e37-d056-462a-9df5-2105e16504d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017029
Listing Expiration 2026-12-31
Marketing Start 1972-02-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323540
Hyphenated Format 63323-540

Supplemental Identifiers

RxCUI
1361226 1361615
UPC
0363323540074 0363323262099
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 NDA017029 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1000 [USP'U]/mL
source: ndc
Packaging
  • 25 VIAL, MULTI-DOSE in 1 TRAY (63323-540-67) / 10 mL in 1 VIAL, MULTI-DOSE (63323-540-07)
source: ndc

Packages (1)

63323-540-67 25 VIAL, MULTI-DOSE in 1 TRAY (63323-540-67) / 10 mL in 1 VIAL, MULTI-DOSE (63323-540-07)

Ingredients (1)

heparin sodium (1000 [USP'U]/mL)

Linked Drug Pages (3)

Heparin Sodium ndc-match (0.9) Heparin Sodium ndc-match (0.9) Heparin Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "df982e37-d056-462a-9df5-2105e16504d2", "openfda": {"upc": ["0363323540074", "0363323262099"], "unii": ["ZZ45AB24CA"], "rxcui": ["1361226", "1361615"], "spl_set_id": ["ed937dd2-8fab-4875-a1e8-627b71ccb7fb"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 TRAY (63323-540-67)  / 10 mL in 1 VIAL, MULTI-DOSE (63323-540-07)", "package_ndc": "63323-540-67", "marketing_start_date": "20200325"}], "brand_name": "Heparin Sodium", "product_id": "63323-540_df982e37-d056-462a-9df5-2105e16504d2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anti-coagulant [EPC]", "Heparin [CS]", "Unfractionated Heparin [EPC]"], "product_ndc": "63323-540", "generic_name": "HEPARIN SODIUM", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Heparin Sodium", "active_ingredients": [{"name": "HEPARIN SODIUM", "strength": "1000 [USP'U]/mL"}], "application_number": "NDA017029", "marketing_category": "NDA", "marketing_start_date": "19720222", "listing_expiration_date": "20261231"}