Dextrose

Product NDC
0990-7930
11-digit product format
009907930
Labeler code
0990
Product ID
0990-7930_ea5b9574-2321-442f-b550-3ac4f10dcaf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dextrose monohydrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
ICU Medical, Inc.
Application
NDA018080
Marketing category
NDA
Marketing start
2019-07-15
Substance
DEXTROSE MONOHYDRATE
Active strength
10 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018080-001DEXTROSE 10% IN PLASTIC CONTAINERDEXTROSE10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N018080-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018080-001DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N018080-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018080-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018080-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018080-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018080-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018080-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018080-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018080-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018080-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018080-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018080-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018080-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018080-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018080-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018080-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018080-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018080-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018080-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018080-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018080-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018080-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018080-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N018080-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018080-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018080-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018080-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N018080-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018080-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018080-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018080-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018080-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018080-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018080-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018080-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018080-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018080-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018080-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018080-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018080-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018080-001AP1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Dextrose
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE MONOHYDRATE10 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LX22YL083GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1795477Internal RxNorm lookup
1795480Internal RxNorm lookup
1795481Internal RxNorm lookup
1795607Internal RxNorm lookup
1795609Internal RxNorm lookup
1795610Internal RxNorm lookup
1795612Internal RxNorm lookup
1795616Internal RxNorm lookup
1795618Internal RxNorm lookup
1795621Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8b25b7e0-703e-4b43-a4eb-52863511602dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0990-7930-02Dextrose1 in 1 POUCHINJECTION, SOLUTION117
0990-7930-02Dextrose24 in 1 CASEINJECTION, SOLUTION2417
0990-7930-03Dextrose24 in 1 CASEINJECTION, SOLUTION2417
0990-7930-03Dextrose1 in 1 POUCHINJECTION, SOLUTION117
0990-7930-09Dextrose12 in 1 CASEINJECTION, SOLUTION1217
0990-7930-09Dextrose1 in 1 POUCHINJECTION, SOLUTION117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0990-7930-02ML - Milliliter0990-79302aee413e-070c-4527-b0d2-40ed731a13a912019-09-05
0990-7930-03ML - Milliliter0990-7930e6853d2f-79a1-454b-a616-53bbf7b0c1d312021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0990-7930DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [ICU MEDICAL INC.]12Current NDC, Legacy NDC, 6 package rows20240711_8b25b7e0-703e-4b43-a4eb-52863511602d.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DextroseDEXTROSE MONOHYDRATEICU Medical, Inc.8b25b7e0-703e-4b43-a4eb-52863511602d2025-11-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 018080
application number: NDA018080
ndc (product): 0990-7930
DextroseDEXTROSE MONOHYDRATEICU Medical, Inc.cb578dba-094c-4787-951d-763d12fd06e12025-11-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 018080
application number: NDA018080

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1795481dextrose 10 % in 1000 ML InjectionPSN8b25b7e0-703e-4b43-a4eb-52863511602d17
1795480dextrose 10 % in 250 ML InjectionPSN8b25b7e0-703e-4b43-a4eb-52863511602d17
1795477dextrose 10 % in 500 ML InjectionPSN8b25b7e0-703e-4b43-a4eb-52863511602d17
1795609dextrose 5 % in 100 ML InjectionPSN8b25b7e0-703e-4b43-a4eb-52863511602d17
1795612dextrose 5 % in 1000 ML InjectionPSN8b25b7e0-703e-4b43-a4eb-52863511602d17
1795621dextrose 5 % in 150 ML InjectionPSN8b25b7e0-703e-4b43-a4eb-52863511602d17
1795618dextrose 5 % in 25 ML InjectionPSN8b25b7e0-703e-4b43-a4eb-52863511602d17
1795610dextrose 5 % in 250 ML InjectionPSN8b25b7e0-703e-4b43-a4eb-52863511602d17
1795616dextrose 5 % in 50 ML InjectionPSN8b25b7e0-703e-4b43-a4eb-52863511602d17
1795607dextrose 5 % in 500 ML InjectionPSN8b25b7e0-703e-4b43-a4eb-52863511602d17
1795609100 ML glucose 50 MG/ML InjectionSCD8b25b7e0-703e-4b43-a4eb-52863511602d17
17954811000 ML glucose 100 MG/ML InjectionSCD8b25b7e0-703e-4b43-a4eb-52863511602d17
17956121000 ML glucose 50 MG/ML InjectionSCD8b25b7e0-703e-4b43-a4eb-52863511602d17
1795621150 ML glucose 50 MG/ML InjectionSCD8b25b7e0-703e-4b43-a4eb-52863511602d17
179561825 ML glucose 50 MG/ML InjectionSCD8b25b7e0-703e-4b43-a4eb-52863511602d17
1795480250 ML glucose 100 MG/ML InjectionSCD8b25b7e0-703e-4b43-a4eb-52863511602d17
1795610250 ML glucose 50 MG/ML InjectionSCD8b25b7e0-703e-4b43-a4eb-52863511602d17
179561650 ML glucose 50 MG/ML InjectionSCD8b25b7e0-703e-4b43-a4eb-52863511602d17
1795477500 ML glucose 100 MG/ML InjectionSCD8b25b7e0-703e-4b43-a4eb-52863511602d17
1795607500 ML glucose 50 MG/ML InjectionSCD8b25b7e0-703e-4b43-a4eb-52863511602d17
1795481dextrose 10 % per 1000 ML InjectionSY8b25b7e0-703e-4b43-a4eb-52863511602d17
1795480dextrose 10 % per 250 ML InjectionSY8b25b7e0-703e-4b43-a4eb-52863511602d17
1795477dextrose 10 % per 500 ML InjectionSY8b25b7e0-703e-4b43-a4eb-52863511602d17
1795609dextrose 5 % per 100 ML InjectionSY8b25b7e0-703e-4b43-a4eb-52863511602d17
1795612dextrose 5 % per 1000 ML InjectionSY8b25b7e0-703e-4b43-a4eb-52863511602d17
1795621dextrose 5 % per 150 ML InjectionSY8b25b7e0-703e-4b43-a4eb-52863511602d17
1795618dextrose 5 % per 25 ML InjectionSY8b25b7e0-703e-4b43-a4eb-52863511602d17
1795610dextrose 5 % per 250 ML InjectionSY8b25b7e0-703e-4b43-a4eb-52863511602d17
1795616dextrose 5 % per 50 ML InjectionSY8b25b7e0-703e-4b43-a4eb-52863511602d17
1795607dextrose 5 % per 500 ML InjectionSY8b25b7e0-703e-4b43-a4eb-52863511602d17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0990-7930-020099079300224 POUCH in 1 CASE (0990-7930-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG24 pouch2019-08-010000-00-00NoNoCurrent
0990-7930-030099079300324 POUCH in 1 CASE (0990-7930-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG24 pouch2019-08-010000-00-00NoNoCurrent
0990-7930-090099079300912 POUCH in 1 CASE (0990-7930-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG12 pouch2019-08-010000-00-00NoNoCurrent