Dextrose

Product NDC
17271-720
Requested package NDC
17271-720-03
11-digit product format
172710720
Labeler code
17271
Product ID
17271-720_00553bc9-c0a8-4b3d-95d1-65f2b8a7e021
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextrose Monohydrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Becton Dickinson and Company
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage17271-72017271-720-03IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage17271-72017271-720-03IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage17271-72017271-720-03IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…

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
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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207449-001DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAP2016-10-21caaa826d4ba7…
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…

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 06:07:402026-07A207449-001AP1caaa826d4ba7…
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…

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
c1f72bce-4bef-49db-a8da-f26a703d6748Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17271-720-02Dextrose60 in 1 CASEINJECTION, SOLUTION606
17271-720-02Dextrose50 mL in 1 BAGINJECTION, SOLUTION506
17271-720-03Dextrose50 in 1 CASEINJECTION, SOLUTION506
17271-720-03Dextrose100 mL in 1 BAGINJECTION, SOLUTION1006
17271-720-05Dextrose30 in 1 CASEINJECTION, SOLUTION306
17271-720-05Dextrose250 mL in 1 BAGINJECTION, SOLUTION2506
17271-720-06Dextrose500 mL in 1 BAGINJECTION, SOLUTION5006
17271-720-06Dextrose20 in 1 CASEINJECTION, SOLUTION206
17271-720-07Dextrose10 in 1 CASEINJECTION, SOLUTION106
17271-720-07Dextrose1000 mL in 1 BAGINJECTION, SOLUTION10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17271-720-02ML - Milliliter17271-720518cc845-9550-4215-a44d-a4b457429b7f12021-04-08
17271-720-03ML - Milliliter17271-720faeb1a06-8beb-4012-abcc-064c5895ad2b12018-11-06
17271-720-05ML - Milliliter17271-72052280dd3-69dd-4151-a8d1-15f85b3741c812018-11-06
17271-720-06ML - Milliliter17271-72019172dd1-955e-467d-ac1e-e4362c59efc212018-11-06
17271-720-07ML - Milliliter17271-720e5b81c73-51c9-471a-b1ff-cbeba9d2bf9712018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17271-720DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [BECTON DICKINSON AND COMPANY]6Current NDC, Legacy NDC, 10 package rows20240823_c1f72bce-4bef-49db-a8da-f26a703d6748.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
ndc (package): 17271-720-03
ndc (product): 17271-720
ndc11 (package): 17271072003
DextroseDEXTROSE MONOHYDRATEFresenius Kabi USA, LLCf2379398-a07b-417e-a022-f7b41f9620672024-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207449
application number: ANDA207449

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1795609dextrose 5 % in 100 ML InjectionPSNc1f72bce-4bef-49db-a8da-f26a703d67486
1795612dextrose 5 % in 1000 ML InjectionPSNc1f72bce-4bef-49db-a8da-f26a703d67486
1795610dextrose 5 % in 250 ML InjectionPSNc1f72bce-4bef-49db-a8da-f26a703d67486
1795616dextrose 5 % in 50 ML InjectionPSNc1f72bce-4bef-49db-a8da-f26a703d67486
1795607dextrose 5 % in 500 ML InjectionPSNc1f72bce-4bef-49db-a8da-f26a703d67486
1795609100 ML glucose 50 MG/ML InjectionSCDc1f72bce-4bef-49db-a8da-f26a703d67486
17956121000 ML glucose 50 MG/ML InjectionSCDc1f72bce-4bef-49db-a8da-f26a703d67486
1795610250 ML glucose 50 MG/ML InjectionSCDc1f72bce-4bef-49db-a8da-f26a703d67486
179561650 ML glucose 50 MG/ML InjectionSCDc1f72bce-4bef-49db-a8da-f26a703d67486
1795607500 ML glucose 50 MG/ML InjectionSCDc1f72bce-4bef-49db-a8da-f26a703d67486
1795609dextrose 5 % per 100 ML InjectionSYc1f72bce-4bef-49db-a8da-f26a703d67486
1795612dextrose 5 % per 1000 ML InjectionSYc1f72bce-4bef-49db-a8da-f26a703d67486
1795610dextrose 5 % per 250 ML InjectionSYc1f72bce-4bef-49db-a8da-f26a703d67486
1795616dextrose 5 % per 50 ML InjectionSYc1f72bce-4bef-49db-a8da-f26a703d67486
1795607dextrose 5 % per 500 ML InjectionSYc1f72bce-4bef-49db-a8da-f26a703d67486

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17271-720-031727107200350 BAG in 1 CASE (17271-720-03) / 100 mL in 1 BAG50 bag2020-03-090000-00-00NoNoCurrent