Home NDC 0338-0719 DEXTROSE
Product NDC 0338-0719
11-digit product format 003380719
Labeler code 0338
Product ID 0338-0719_aa64f648-e931-4a99-9b81-791a3827272c
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 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0338-0719-13 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0338-0719-13 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0338-0719-13 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0338-0719-13 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0338-0719-13 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0338-0719-13 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0338-0719-13 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0338-0719-13 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0338-0719-13 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0338-0719-13 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0338-0719-13 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0338-0719-13 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 126 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 2026-08-18 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…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020047-002 DEXTROSE 60% IN PLASTIC CONTAINER 60GM/100ML INJECTABLE / INJECTION 1991-07-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020047-003 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020047-001 DEXTROSE 50% IN PLASTIC CONTAINER 50GM/100ML INJECTABLE / INJECTION AP RLD, RS 1991-07-02 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DEXTROSE DEXTROSE MONOHYDRATE Baxter Healthcare Corporation 0332f34a-7038-47cc-ba59-d55cad6b73ca 2019-08-05 Warnings, Adverse reactions Exact identifier application applno (NDA): 020047 application number: NDA020047 ndc (product): 0338-0719
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