Home NDC 0338-9653 DEXTROSE
Product NDC 0338-9653
11-digit product format 003389653
Labeler code 0338
Product ID 0338-9653_b28d6bb9-8496-48bd-b6aa-f67996d0829c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dextrose monohydrate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application NDA016673
Marketing category NDA
Marketing start 1971-03-04
Substance DEXTROSE MONOHYDRATE
Active strength 5 g/100mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N016673-001 DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 5GM/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 N016673-003 DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1985-10-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 of 3 · 86 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 N016673-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N016673-003 DEXTROSE 5% IN PLASTIC CONTAINER 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1985-10-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N016673-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N016673-003 DEXTROSE 5% IN PLASTIC CONTAINER 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1985-10-30 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N016673-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N016673-003 DEXTROSE 5% IN PLASTIC CONTAINER 50MG/ML INJECTABLE / INJECTION AP RLD, RS 1985-10-30 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base DEXTROSE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROSE MONOHYDRATE 5 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LX22YL083G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1795607 Internal RxNorm lookup 1795609 Internal RxNorm lookup 1795610 Internal RxNorm lookup 1795612 Internal RxNorm lookup 1795616 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0338-9653-60 DEXTROSE 100 mL in 1 BAG INJECTION, SOLUTION 100 10 0338-9653-60 DEXTROSE 60 in 1 CARTON INJECTION, SOLUTION 60 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-9653 DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 10 Current NDC, 2 package rows 20250516_36e9478c-5df0-4b47-b97d-de3626d7cb29.zip
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0338-9653-60 00338965360 60 BAG in 1 CARTON (0338-9653-60) / 100 mL in 1 BAG 60 bag 2024-08-09 No No Current