Home NDC 0338-0719-06 DEXTROSE
Product NDC 0338-0719
Requested package NDC 0338-0719-06
11-digit product format 003380719
Labeler code 0338
Product ID 0338-0719_fa107ac2-32b9-452f-b26c-0a5df79e31ab
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dextrose monohydrate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application NDA020047
Marketing category NDA
Marketing start 1991-07-02
Substance DEXTROSE MONOHYDRATE
Active strength 70 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 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER DEXTROSE 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER DEXTROSE 60GM/100ML INJECTABLE / INJECTION 1991-07-02 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER DEXTROSE 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02
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 1 of 4 · 132 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 2026-10-15 13:18:30 2026-09 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 c2088c7a36db…2026-09-14 22:38:34 2026-08 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 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 70 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 237656 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 0338-0719-06 DEXTROSE 2000 mL in 1 BAG INJECTION, SOLUTION 2000 15
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-0719 DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 15 Current NDC, Legacy NDC, 1 package rows 20250516_0332f34a-7038-47cc-ba59-d55cad6b73ca.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0338-0719-06 00338071906 2000 mL in 1 BAG (0338-0719-06) 2000 ml 1991-07-02 0000-00-00 No No Current