Dextrose Monohydrate

Product NDC
71872-7282
11-digit product format
718727282
Labeler code
71872
Product ID
71872-7282_ea75f790-621c-3fb6-e053-2995a90af28b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextrose Monohydrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA203451
Marketing category
ANDA
Marketing start
2021-11-11
Substance
DEXTROSE MONOHYDRATE
Active strength
25 g/50mL
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
A203451-001DEXTROSE 50%DEXTROSE500MG/MLINJECTABLE / INJECTIONAP2021-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203451-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-264b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-2687673890dc5c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-26cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203451-001DEXTROSE 50%500MG/MLINJECTABLE / INJECTIONAP2021-03-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203451-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203451-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203451-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203451-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203451-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203451-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203451-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203451-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203451-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203451-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203451-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203451-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203451-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203451-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203451-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203451-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203451-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203451-001AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A203451-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203451-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203451-001AP187673890dc5c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203451-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203451-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203451-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203451-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203451-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203451-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203451-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203451-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203451-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203451-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203451-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203451-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203451-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203451-001AP1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE MONOHYDRATE25 g/50mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
727517Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dc6664a6-1be1-676c-e053-2995a90a3490Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71872-7282-1Dextrose Monohydrate50 mL in 1 SYRINGEINJECTION, SOLUTION502
71872-7282-1Dextrose Monohydrate1 in 1 BAGINJECTION, SOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7282DEXTROSE MONOHYDRATE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]2Current NDC, Legacy NDC, 2 package rows20221008_dc6664a6-1be1-676c-e053-2995a90a3490.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dextrose monohydrateDEXTROSE MONOHYDRATEHF Acquisition Co LLC, DBA HealthFirstd7c4f9eb-9b89-c5a3-e053-2a95a90a28a22024-02-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203451
application number: ANDA203451
Dextrose MonohydrateDEXTROSE MONOHYDRATEInternational Medication Systems, Limitedfcc7ac79-cd70-4f03-a4de-f051f9ca1f7d2022-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203451
application number: ANDA203451
Dextrose MonohydrateDEXTROSE MONOHYDRATEMedical Purchasing Solutions, LLCdc6664a6-1be1-676c-e053-2995a90a34902022-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203451
application number: ANDA203451
ndc (product): 71872-7282

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727517dextrose 50 % in 50 ML Prefilled SyringePSNdc6664a6-1be1-676c-e053-2995a90a34902
72751750 ML glucose 500 MG/ML Prefilled SyringeSCDdc6664a6-1be1-676c-e053-2995a90a34902
72751750 ML dextrose 50 % Prefilled SyringeSYdc6664a6-1be1-676c-e053-2995a90a34902
727517dextrose 25 GM per 50 ML Prefilled SyringeSYdc6664a6-1be1-676c-e053-2995a90a34902

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71872-7282-1718727282011 SYRINGE in 1 BAG (71872-7282-1) / 50 mL in 1 SYRINGE1 syringe2022-03-010000-00-00NoNoCurrent