Home NDC 0990-7937 Dextrose
Product NDC 0990-7937
11-digit product format 009907937
Labeler code 0990
Product ID 0990-7937_6785bd83-c705-41a5-a19c-906f03f380e3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dextrose
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler ICU Medical Inc.
Application NDA018562
Marketing category NDA
Marketing start 2019-10-01
Substance DEXTROSE MONOHYDRATE
Active strength 40 g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
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 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER DEXTROSE 40GM/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 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018562-001 DEXTROSE 40% IN PLASTIC CONTAINER 40GM/100ML INJECTABLE / INJECTION RLD, RS 1982-03-23 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Dextrose
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROSE MONOHYDRATE 40 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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 237649 Internal RxNorm lookup 237650 Internal RxNorm lookup 237656 Internal RxNorm lookup 242694 Internal RxNorm lookup 1795518 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 0990-7937-19 Dextrose 1 in 1 POUCH INJECTION, SOLUTION 1 7 0990-7937-19 Dextrose 12 in 1 CASE INJECTION, SOLUTION 12 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0990-7937 DEXTROSE INJECTION, SOLUTION [ICU MEDICAL INC.] 5 Current NDC, Legacy NDC, 2 package rows 20231202_b5cb7a5a-bbe8-4217-a82e-da818f7771c9.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 0990-7937-19 00990793719 12 POUCH in 1 CASE (0990-7937-19) / 1 BAG in 1 POUCH / 500 mL in 1 BAG 12 pouch 2019-10-01 0000-00-00 No No Current