Home NDC 0409-7100 Dextrose
Product NDC 0409-7100
11-digit product format 004097100
Labeler code 0409
Product ID 0409-7100_033b46e6-d83b-4c4f-8329-4bba3e0617b5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dextrose monohydrate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application NDA019466
Marketing category NDA
Marketing start 2005-06-27
Marketing end 2026-11-30
Substance DEXTROSE MONOHYDRATE
Active strength 50 mg/mL
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 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 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019466-001 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 · 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 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019466-001 DEXTROSE 5% IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP RLD, RS 1985-07-15 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Dextrose Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROSE MONOHYDRATE 50 mg/mL
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1795609 Internal RxNorm lookup 1795610 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 0409-7100-02 Dextrose 2 in 1 POUCH INJECTION, SOLUTION 2 26 0409-7100-02 Dextrose 12 in 1 CASE INJECTION, SOLUTION 12 26 0409-7100-04 Dextrose 250 mL in 1 BAG INJECTION, SOLUTION 250 26 0409-7100-66 Dextrose 5 in 1 POUCH INJECTION, SOLUTION 5 26 0409-7100-66 Dextrose 10 in 1 CASE INJECTION, SOLUTION 10 26 0409-7100-67 Dextrose 5 in 1 POUCH INJECTION, SOLUTION 5 26 0409-7100-67 Dextrose 10 in 1 CASE INJECTION, SOLUTION 10 26 0409-7100-68 Dextrose 50 mL in 1 BAG INJECTION, SOLUTION 50 26 0409-7100-69 Dextrose 100 mL in 1 BAG INJECTION, SOLUTION 100 26
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-7100 DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [HOSPIRA, INC.] 24 Current NDC, Legacy NDC, 9 package rows 20211020_10e98cb0-31a5-4ad1-3eaa-aa4af387a42d.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0409-7100-02 00409710002 12 POUCH in 1 CASE (0409-7100-02) / 2 BAG in 1 POUCH / 250 mL in 1 BAG (0409-7100-04) 12 pouch 2005-06-27 0000-00-00 No No Current 0409-7100-04 00409710004 250 mL in 1 BAG 250 ml Historical 0409-7100-66 00409710066 10 POUCH in 1 CASE (0409-7100-66) / 5 BAG in 1 POUCH / 50 mL in 1 BAG (0409-7100-68) 10 pouch 2005-08-04 0000-00-00 No No Current 0409-7100-67 00409710067 10 POUCH in 1 CASE (0409-7100-67) / 5 BAG in 1 POUCH / 100 mL in 1 BAG (0409-7100-69) 10 pouch 2005-09-14 0000-00-00 No No Current 0409-7100-68 00409710068 50 mL in 1 BAG 50 ml Historical 0409-7100-69 00409710069 100 mL in 1 BAG 100 ml Historical