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Last Updated: July 2, 2020

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Details for New Drug Application (NDA): 018609


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NDA 018609 describes HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.

The generic ingredient in HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is heparin sodium. There are seventy-seven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.
Summary for 018609
Pharmacology for NDA: 018609
Suppliers and Packaging for NDA: 018609
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER heparin sodium INJECTABLE;INJECTION 018609 NDA AUTHORIZED GENERIC Baxter Healthcare Corporation 0338-0424 0338-0424-18 18 BAG in 1 CARTON (0338-0424-18) > 500 mL in 1 BAG
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER heparin sodium INJECTABLE;INJECTION 018609 NDA Baxter Healthcare Corporation 0338-0428 0338-0428-12 12 BAG in 1 CARTON (0338-0428-12) > 1000 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200 UNITS/100ML
Approval Date:Apr 28, 1982TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200 UNITS/100ML
Approval Date:Apr 28, 1982TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength500 UNITS/100ML
Approval Date:Apr 28, 1982TE:RLD:No

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