Home Applications 016367 Application 016367
Type NDA
Sponsor ICU MEDICAL INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE INJECTABLE;INJECTION 50MG/ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N016367-002 DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 50MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N016367-002 AP
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 2 of 2 · 43 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 2022-09-29 23:25 UTC 2022-09 N016367-002 DEXTROSE 5% IN PLASTIC CONTAINER 50MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N016367-002 DEXTROSE 5% IN PLASTIC CONTAINER 50MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N016367-002 DEXTROSE 5% IN PLASTIC CONTAINER 50MG/ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 · 43 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0409-7922 Dextrose dextrose monohydrate Hospira, Inc. NDA Current 0409-7922 Dextrose dextrose monohydrate Hospira, Inc. NDA Current 0409-7922 Dextrose dextrose monohydrate Hospira, Inc. NDA Current 0409-7922 Dextrose dextrose monohydrate Hospira, Inc. NDA Current 0409-7922 Dextrose dextrose monohydrate Hospira, Inc. NDA Current 0409-7922 Dextrose dextrose monohydrate Hospira, Inc. NDA Current 0409-7923 Dextrose dextrose monohydrate Hospira, Inc. NDA Current 0409-7923 Dextrose dextrose monohydrate Hospira, Inc. NDA Current 0409-7923 Dextrose dextrose monohydrate Hospira, Inc. NDA Current 0409-7923 Dextrose dextrose monohydrate Hospira, Inc. NDA Current 0409-7923 Dextrose dextrose monohydrate Hospira, Inc. NDA Current 0409-7923 Dextrose dextrose monohydrate Hospira, Inc. NDA Current 0990-7922 Dextrose dextrose monohydrate ICU Medical Inc. NDA Current 0990-7922 Dextrose dextrose monohydrate ICU Medical Inc. NDA Current 0990-7922 Dextrose dextrose monohydrate ICU Medical Inc. NDA Current 0990-7922 Dextrose dextrose monohydrate ICU Medical Inc. NDA Current 0990-7922 Dextrose dextrose monohydrate ICU Medical Inc. NDA Current 0990-7922 Dextrose dextrose monohydrate ICU Medical Inc. NDA Current 0990-7922 Dextrose dextrose monohydrate ICU Medical Inc. NDA Current 0990-7922 Dextrose dextrose monohydrate ICU Medical Inc. NDA Current 0990-7922 Dextrose dextrose monohydrate ICU Medical Inc. NDA Current 0990-7923 Dextrose dextrose monohydrate ICU Medical Inc. NDA Current 0990-7923 Dextrose dextrose monohydrate ICU Medical Inc. NDA Current 0990-7923 Dextrose dextrose monohydrate ICU Medical Inc. NDA Current 0990-7923 Dextrose dextrose monohydrate ICU Medical Inc. NDA Current 0990-7923 Dextrose dextrose monohydrate ICU Medical Inc. NDA Current 0990-7923 Dextrose dextrose monohydrate ICU Medical Inc. NDA Current 0990-7923 Dextrose dextrose monohydrate ICU Medical Inc. NDA Current 0990-7923 Dextrose dextrose monohydrate ICU Medical Inc. NDA Current 0990-7923 Dextrose dextrose monohydrate ICU Medical Inc. NDA Current 51662-1211 5% DEXTROSE 5% DEXTROSE HF Acquisition Co LLC, DBA HealthFirst NDA Current 51662-1211 5% DEXTROSE 5% DEXTROSE HF Acquisition Co LLC, DBA HealthFirst NDA Current 51662-1211 5% DEXTROSE 5% DEXTROSE HF Acquisition Co LLC, DBA HealthFirst NDA Current 51662-1214 DEXTROSE DEXTROSE HF Acquisition Co LLC, DBA HealthFirst NDA Current 51662-1214 DEXTROSE DEXTROSE HF Acquisition Co LLC, DBA HealthFirst NDA Current 51662-1214 DEXTROSE DEXTROSE HF Acquisition Co LLC, DBA HealthFirst NDA Current 51662-1306 DEXTROSE DEXTROSE HF Acquisition Co LLC, DBA HealthFirst NDA Current 51662-1306 DEXTROSE DEXTROSE HF Acquisition Co LLC, DBA HealthFirst NDA Current 51662-1306 DEXTROSE DEXTROSE HF Acquisition Co LLC, DBA HealthFirst NDA Current 51662-1413 5% DEXTROSE 5% DEXTROSE HF Acquisition Co LLC, DBA HealthFirst NDA Current 51662-1413 5% DEXTROSE 5% DEXTROSE HF Acquisition Co LLC, DBA HealthFirst NDA Current 51662-1493 DEXTROSE MONOHYDRATE DEXTROSE MONOHYDRATE HF Acquisition Co LLC, DBA HealthFirst NDA Current 51662-1493 DEXTROSE MONOHYDRATE DEXTROSE MONOHYDRATE HF Acquisition Co LLC, DBA HealthFirst NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 82526 SUPPL 2025-06-10 82518 SUPPL 2025-06-10 12991 SUPPL 2006-10-31 10888 SUPPL 2006-10-27 10887 SUPPL 2005-09-07 442 SUPPL 2005-09-07