Home NDC 0409-7918-19 Dextrose
Product NDC 0409-7918
Requested package NDC 0409-7918-19
11-digit product format 004097918
Labeler code 0409
Product ID 0409-7918_f22bcda2-771d-4ac9-b69b-f8fe36205568
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dextrose
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application NDA018561
Marketing category NDA
Marketing start 2005-07-14
Marketing end 2021-08-01
Substance DEXTROSE MONOHYDRATE
Active strength 70 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER DEXTROSE 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018561-001 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 1 of 2 · 41 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 2026-02-19 14:30 UTC 2026-02 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018561-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1982-03-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 0409-7918-19 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 0409-7918-19 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0409-7918-19 00409791819 12 POUCH in 1 CASE (0409-7918-19) > 1 BAG in 1 POUCH > 500 mL in 1 BAG 12 pouch 2005-07-14 2021-08-01 No No Current