Dextrose

Product NDC
63323-624
11-digit product format
633230624
Labeler code
63323
Product ID
63323-624_40c07bed-7ccc-4117-a595-78c2a053e8a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextrose Monohydrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA207449
Marketing category
ANDA
Marketing start
2016-10-21
Substance
DEXTROSE MONOHYDRATE
Active strength
50 mg/mL
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 1.

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
A207449-001DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE50MG/MLINJECTABLE / INJECTIONAP2016-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207449-001AP

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-213f01610625f2…
2019-09-15 20:21 UTC2019-09A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-21cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207449-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207449-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207449-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207449-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207449-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207449-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207449-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207449-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207449-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207449-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207449-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207449-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207449-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207449-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207449-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207449-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207449-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207449-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207449-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207449-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207449-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A207449-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207449-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207449-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207449-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A207449-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207449-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207449-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207449-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207449-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207449-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207449-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207449-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207449-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207449-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207449-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207449-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207449-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207449-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207449-001AP1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Dextrose
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE MONOHYDRATE50 mg/mL

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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1795607Internal RxNorm lookup
1795609Internal RxNorm lookup
1795610Internal RxNorm lookup
1795612Internal RxNorm lookup
1795616Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f2379398-a07b-417e-a022-f7b41f962067Available 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
63323-624-03Dextrose1000 mL in 1 BAGINJECTION, SOLUTION10007
63323-624-04Dextrose250 mL in 1 BAGINJECTION, SOLUTION2507
63323-624-05Dextrose50 mL in 1 BAGINJECTION, SOLUTION507
63323-624-06Dextrose100 mL in 1 BAGINJECTION, SOLUTION1007
63323-624-07Dextrose500 mL in 1 BAGINJECTION, SOLUTION5007
63323-624-10Dextrose10 in 1 CASEINJECTION, SOLUTION107
63323-624-50Dextrose60 in 1 CASEINJECTION, SOLUTION607
63323-624-61Dextrose50 in 1 CASEINJECTION, SOLUTION507
63323-624-74Dextrose30 in 1 CASEINJECTION, SOLUTION307
63323-624-75Dextrose20 in 1 CASEINJECTION, SOLUTION207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-624-03ML - Milliliter63323-6244fb0b62e-c170-41e3-8d55-d6686d07255312025-01-14
63323-624-04ML - Milliliter63323-624ba451c15-d000-40d8-9ec2-6db27b773b5112020-08-06
63323-624-05ML - Milliliter63323-62433091252-80e7-492f-ba23-0be7b1d8c39f12019-12-10
63323-624-06ML - Milliliter63323-6243ee3424e-6480-4d76-871b-ab4784f1fbfc12020-08-06
63323-624-07ML - Milliliter63323-624f7722f8f-0f2f-4987-9bfc-d332eb0817a812022-07-06
63323-624-10ML - Milliliter63323-62445426336-b95c-4b96-a8ab-332e39fe707612017-07-07
63323-624-50ML - Milliliter63323-624d4c7bafa-ccd8-4dc3-8a91-bc61ed75c61312019-12-10
63323-624-61ML - Milliliter63323-62473465176-b942-4554-9c19-8b18e365583712017-10-13
63323-624-74ML - Milliliter63323-62431e4494f-ab9f-42cf-aa90-b0c1859aef5112017-05-04
63323-624-75ML - Milliliter63323-624af12bccc-8f36-4e89-8020-20faa4cb4c3412017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-624DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC, 10 package rows20240427_f2379398-a07b-417e-a022-f7b41f962067.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DextroseDEXTROSE MONOHYDRATEBECTON DICKINSON AND COMPANY32132016-1870-481b-9816-e11beb03ca0b2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207449
application number: ANDA207449
DextroseDEXTROSE MONOHYDRATEFresenius Kabi USA, LLCbd250a46-d229-4e80-b5a1-b34169ccecc42025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207449
application number: ANDA207449
DextroseDEXTROSE MONOHYDRATEProPharma Distribution3eff8bcd-6a33-428f-e063-6394a90afa682025-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207449
application number: ANDA207449
DextroseDEXTROSE MONOHYDRATEFRESENIUS KABI USA, LLC576a22d8-5f2f-497e-80ad-1842ca74bb532024-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207449
application number: ANDA207449
DextroseDEXTROSE MONOHYDRATEBecton Dickinson and Companyc1f72bce-4bef-49db-a8da-f26a703d67482024-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207449
application number: ANDA207449
DextroseDEXTROSE MONOHYDRATEFresenius Kabi USA, LLCf2379398-a07b-417e-a022-f7b41f9620672024-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207449
application number: ANDA207449
ndc (product): 63323-624

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1795609dextrose 5 % in 100 ML InjectionPSNf2379398-a07b-417e-a022-f7b41f9620677
1795612dextrose 5 % in 1000 ML InjectionPSNf2379398-a07b-417e-a022-f7b41f9620677
1795610dextrose 5 % in 250 ML InjectionPSNf2379398-a07b-417e-a022-f7b41f9620677
1795616dextrose 5 % in 50 ML InjectionPSNf2379398-a07b-417e-a022-f7b41f9620677
1795607dextrose 5 % in 500 ML InjectionPSNf2379398-a07b-417e-a022-f7b41f9620677
1795609100 ML glucose 50 MG/ML InjectionSCDf2379398-a07b-417e-a022-f7b41f9620677
17956121000 ML glucose 50 MG/ML InjectionSCDf2379398-a07b-417e-a022-f7b41f9620677
1795610250 ML glucose 50 MG/ML InjectionSCDf2379398-a07b-417e-a022-f7b41f9620677
179561650 ML glucose 50 MG/ML InjectionSCDf2379398-a07b-417e-a022-f7b41f9620677
1795607500 ML glucose 50 MG/ML InjectionSCDf2379398-a07b-417e-a022-f7b41f9620677
1795609dextrose 5 % per 100 ML InjectionSYf2379398-a07b-417e-a022-f7b41f9620677
1795612dextrose 5 % per 1000 ML InjectionSYf2379398-a07b-417e-a022-f7b41f9620677
1795610dextrose 5 % per 250 ML InjectionSYf2379398-a07b-417e-a022-f7b41f9620677
1795616dextrose 5 % per 50 ML InjectionSYf2379398-a07b-417e-a022-f7b41f9620677
1795607dextrose 5 % per 500 ML InjectionSYf2379398-a07b-417e-a022-f7b41f9620677

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-624-03633230624031000 mL in 1 BAG1000 mlHistorical
63323-624-0463323062404250 mL in 1 BAG250 mlHistorical
63323-624-056332306240550 mL in 1 BAG50 mlHistorical
63323-624-0663323062406100 mL in 1 BAG100 mlHistorical
63323-624-0763323062407500 mL in 1 BAG500 mlHistorical
63323-624-106332306241010 BAG in 1 CASE (63323-624-10) / 1000 mL in 1 BAG (63323-624-03) 10 bag2016-10-210000-00-00NoNoCurrent
63323-624-506332306245060 BAG in 1 CASE (63323-624-50) / 50 mL in 1 BAG (63323-624-05) 60 bag2018-07-310000-00-00NoNoCurrent
63323-624-616332306246150 BAG in 1 CASE (63323-624-61) / 100 mL in 1 BAG (63323-624-06) 50 bag2016-10-210000-00-00NoNoCurrent
63323-624-746332306247430 BAG in 1 CASE (63323-624-74) / 250 mL in 1 BAG (63323-624-04) 30 bag2016-10-210000-00-00NoNoCurrent
63323-624-756332306247520 BAG in 1 CASE (63323-624-75) / 500 mL in 1 BAG (63323-624-07) 20 bag2016-10-210000-00-00NoNoCurrent