Home NDC 0409-7935 Dextrose
Product NDC 0409-7935
11-digit product format 004097935
Labeler code 0409
Product ID 0409-7935_f22bcda2-771d-4ac9-b69b-f8fe36205568
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dextrose
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application NDA018564
Marketing category NDA
Marketing start 2005-09-12
Marketing end 2020-12-01
Substance DEXTROSE MONOHYDRATE
Active strength 20 g/100mL
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 0409-7935-19 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 0409-7935-19 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 0409-7935-19 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 0409-7935-19 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 0409-7935-19 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 0409-7935-19 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 0409-7935-19 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 0409-7935-19 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 0409-7935-19 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 0409-7935-19 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 0409-7935-19 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 0409-7935-19 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER DEXTROSE 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23
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 2 · 42 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 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018564-001 DEXTROSE 20% IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 e64feba35796…
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 0409-7935-19 2020-09-03 C162847 48780-1 ab0e2407-2be4-f274-e053-dbdaa90a6471 These highlights do not include all the information needed to use DEXTROSE INJECTION 20%, 30%, 40%, 50% and 70% safely and effectively. See full prescribing information for DEXTROSE INJECTION 20%, 30%, 40%, 50% and 70%. DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940 0409-7935-19 2020-07-22 C162847 48780-1 ab0e2407-2be4-f274-e053-dbdaa90a6471 These highlights do not include all the information needed to use DEXTROSE INJECTION 20%, 30%, 40%, 50% and 70% safely and effectively. See full prescribing information for DEXTROSE INJECTION 20%, 30%, 40%, 50% and 70%. DEXTROSE injection, for intravenous use Initial U.S. Approval: 1940
DailyMed Socrata Ingredients# 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.