Home NDC 0990-7120 Dextrose
Product NDC 0990-7120
11-digit product format 009907120
Labeler code 0990
Product ID 0990-7120_2221fdbf-4b3f-4296-80bc-96c446156fff
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dextrose monohydrate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler ICU Medical Inc.
Application NDA019893
Marketing category NDA
Marketing start 2019-07-01
Substance DEXTROSE MONOHYDRATE
Active strength 70 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 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER DEXTROSE 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019893-001 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 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019893-001 DEXTROSE 70% IN PLASTIC CONTAINER 70GM/100ML INJECTABLE / INJECTION AP RLD, RS 1989-12-26 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
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 0990-7120-07 Dextrose 1 in 1 POUCH INJECTION, SOLUTION 1 6 0990-7120-07 Dextrose 6 in 1 CASE INJECTION, SOLUTION 6 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0990-7120 DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [ICU MEDICAL INC.] 5 Current NDC, Legacy NDC, 2 package rows 20241101_cdf35d11-fbc8-4f8e-85a8-33220312c0b4.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 0990-7120-07 00990712007 6 POUCH in 1 CASE (0990-7120-07) / 1 BAG in 1 POUCH / 2000 mL in 1 BAG 6 pouch 2019-07-01 0000-00-00 No No Current