Home Applications 019339 Application 019339
Type NDA
Sponsor HOSPIRA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/100ML No No 002 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/100ML No No 003 HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/100ML No No 004 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/100ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019339-001 HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE / INJECTION 1985-03-27 N019339-002 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 10,000 UNITS/100ML INJECTABLE / INJECTION AP 1985-03-27 N019339-003 HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 10,000 UNITS/100ML INJECTABLE / INJECTION AP 1985-03-27 N019339-004 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/100ML INJECTABLE / INJECTION AP 1985-03-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 5 of 5 · 176 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N019339-001 HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION 1985-03-27 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N019339-002 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER 10,000 UNITS/100ML INJECTABLE / INJECTION AP 1985-03-27 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N019339-003 HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER 10,000 UNITS/100ML INJECTABLE / INJECTION AP 1985-03-27 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N019339-004 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION AP 1985-03-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019339-001 HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION 1985-03-27 e64feba35796…2022-09-29 23:25 UTC 2022-09 N019339-002 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER 10,000 UNITS/100ML INJECTABLE / INJECTION AP 1985-03-27 e64feba35796…2022-09-29 23:25 UTC 2022-09 N019339-003 HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER 10,000 UNITS/100ML INJECTABLE / INJECTION AP 1985-03-27 e64feba35796…2022-09-29 23:25 UTC 2022-09 N019339-004 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION AP 1985-03-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019339-001 HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION 1985-03-27 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019339-002 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER 10,000 UNITS/100ML INJECTABLE / INJECTION AP 1985-03-27 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019339-003 HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER 10,000 UNITS/100ML INJECTABLE / INJECTION AP 1985-03-27 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019339-004 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION AP 1985-03-27 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N019339-001 HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION 1985-03-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N019339-002 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER 10,000 UNITS/100ML INJECTABLE / INJECTION AP 1985-03-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N019339-003 HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER 10,000 UNITS/100ML INJECTABLE / INJECTION AP 1985-03-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N019339-004 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER 5,000 UNITS/100ML INJECTABLE / INJECTION AP 1985-03-27 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0409-4520 Heparin Sodium and Dextrose HEPARIN SODIUM Hospira, Inc. NDA Current 0409-7793 Heparin Sodium and Dextrose HEPARIN SODIUM Hospira, Inc. NDA Current 0409-7793 Heparin Sodium and Dextrose HEPARIN SODIUM Hospira, Inc. NDA Current 0409-7793 Heparin Sodium and Dextrose HEPARIN SODIUM Hospira, Inc. NDA Current 0409-7793 Heparin Sodium and Dextrose HEPARIN SODIUM Hospira, Inc. NDA Current 0409-7793 Heparin Sodium and Dextrose HEPARIN SODIUM Hospira, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 77424 SUPPL 2024-02-08 77419 SUPPL 2024-02-07 59918 SUPPL 2019-09-05 59911 SUPPL 2019-09-05 57002 SUPPL 2018-12-21 56964 SUPPL 2018-12-21 11478 SUPPL 2014-03-19 17361 SUPPL 2014-03-18 17360 SUPPL 2011-12-29 33726 SUPPL 2011-12-23 17359 SUPPL 2009-07-31 1288 SUPPL 2008-10-21