DEXTROSE

Product NDC
0264-7520
11-digit product format
002647520
Labeler code
0264
Product ID
0264-7520_c9f87749-8dd5-41fd-b393-f63d45fd00ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXTROSE
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
NDA019626
Marketing category
NDA
Marketing start
1988-02-02
Substance
DEXTROSE, UNSPECIFIED FORM
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 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019626-001DEXTROSE 2.5% IN PLASTIC CONTAINERDEXTROSE2.5GM/100MLINJECTABLE / INJECTION1988-02-02
N019626-002DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE5GM/100MLINJECTABLE / INJECTIONAPRLD, RS1988-02-02
N019626-003DEXTROSE 7.7% IN PLASTIC CONTAINERDEXTROSE7.7GM/100MLINJECTABLE / INJECTION1988-02-02
N019626-004DEXTROSE 10% IN PLASTIC CONTAINERDEXTROSE10GM/100MLINJECTABLE / INJECTIONAPRLD, RS1988-02-02
N019626-005DEXTROSE 70% IN PLASTIC CONTAINERDEXTROSE70GM/100MLINJECTABLE / INJECTIONAPRLD, RS2015-02-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N019626-002AP
N019626-004AP
N019626-005AP

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 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N019626-001DEXTROSE 2.5% IN PLASTIC CONTAINER2.5GM/100MLINJECTABLE / INJECTION1988-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019626-002DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS1988-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019626-003DEXTROSE 7.7% IN PLASTIC CONTAINER7.7GM/100MLINJECTABLE / INJECTION1988-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019626-004DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS1988-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019626-005DEXTROSE 70% IN PLASTIC CONTAINER70GM/100MLINJECTABLE / INJECTIONAPRLD, RS2015-02-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019626-001DEXTROSE 2.5% IN PLASTIC CONTAINER2.5GM/100MLINJECTABLE / INJECTION1988-02-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019626-002DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS1988-02-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019626-003DEXTROSE 7.7% IN PLASTIC CONTAINER7.7GM/100MLINJECTABLE / INJECTION1988-02-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019626-004DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS1988-02-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019626-005DEXTROSE 70% IN PLASTIC CONTAINER70GM/100MLINJECTABLE / INJECTIONAPRLD, RS2015-02-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N019626-001DEXTROSE 2.5% IN PLASTIC CONTAINER2.5GM/100MLINJECTABLE / INJECTION1988-02-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019626-002DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS1988-02-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019626-003DEXTROSE 7.7% IN PLASTIC CONTAINER7.7GM/100MLINJECTABLE / INJECTION1988-02-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019626-004DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS1988-02-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019626-005DEXTROSE 70% IN PLASTIC CONTAINER70GM/100MLINJECTABLE / INJECTIONAPRLD, RS2015-02-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019626-001DEXTROSE 2.5% IN PLASTIC CONTAINER2.5GM/100MLINJECTABLE / INJECTION1988-02-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019626-002DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS1988-02-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019626-003DEXTROSE 7.7% IN PLASTIC CONTAINER7.7GM/100MLINJECTABLE / INJECTION1988-02-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019626-004DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS1988-02-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019626-005DEXTROSE 70% IN PLASTIC CONTAINER70GM/100MLINJECTABLE / INJECTIONAPRLD, RS2015-02-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019626-001DEXTROSE 2.5% IN PLASTIC CONTAINER2.5GM/100MLINJECTABLE / INJECTION1988-02-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019626-002DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS1988-02-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019626-003DEXTROSE 7.7% IN PLASTIC CONTAINER7.7GM/100MLINJECTABLE / INJECTION1988-02-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019626-004DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS1988-02-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019626-005DEXTROSE 70% IN PLASTIC CONTAINER70GM/100MLINJECTABLE / INJECTIONAPRLD, RS2015-02-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019626-001DEXTROSE 2.5% IN PLASTIC CONTAINER2.5GM/100MLINJECTABLE / INJECTION1988-02-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019626-002DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS1988-02-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019626-003DEXTROSE 7.7% IN PLASTIC CONTAINER7.7GM/100MLINJECTABLE / INJECTION1988-02-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019626-004DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS1988-02-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019626-005DEXTROSE 70% IN PLASTIC CONTAINER70GM/100MLINJECTABLE / INJECTIONAPRLD, RS2015-02-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019626-001DEXTROSE 2.5% IN PLASTIC CONTAINER2.5GM/100MLINJECTABLE / INJECTION1988-02-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019626-002DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS1988-02-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019626-003DEXTROSE 7.7% IN PLASTIC CONTAINER7.7GM/100MLINJECTABLE / INJECTION1988-02-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019626-004DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS1988-02-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019626-005DEXTROSE 70% IN PLASTIC CONTAINER70GM/100MLINJECTABLE / INJECTIONAPRLD, RS2015-02-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019626-001DEXTROSE 2.5% IN PLASTIC CONTAINER2.5GM/100MLINJECTABLE / INJECTION1988-02-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019626-002DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS1988-02-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019626-003DEXTROSE 7.7% IN PLASTIC CONTAINER7.7GM/100MLINJECTABLE / INJECTION1988-02-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019626-004DEXTROSE 10% IN PLASTIC CONTAINER10GM/100MLINJECTABLE / INJECTIONAPRLD, RS1988-02-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019626-005DEXTROSE 70% IN PLASTIC CONTAINER70GM/100MLINJECTABLE / INJECTIONAPRLD, RS2015-02-185bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N019626-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019626-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019626-005AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019626-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019626-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019626-005AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019626-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019626-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019626-005AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019626-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019626-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019626-005AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019626-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019626-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019626-005AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019626-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019626-004AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019626-005AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019626-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019626-004AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019626-005AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019626-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019626-004AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019626-005AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019626-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019626-004AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019626-005AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019626-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019626-004AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019626-005AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019626-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019626-004AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019626-005AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019626-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019626-004AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019626-005AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019626-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019626-004AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019626-005AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019626-002AP18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE, UNSPECIFIED FORM10 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IY9XDZ35W2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
085614c7-ada4-4e2c-87c0-c9bc2f18365aAvailable 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
0264-7520-00DEXTROSE1000 mL in 1 CONTAINERSOLUTION100012
0264-7520-00DEXTROSE12 in 1 CASESOLUTION1212
0264-7520-10DEXTROSE500 mL in 1 CONTAINERSOLUTION50012
0264-7520-10DEXTROSE24 in 1 CASESOLUTION2412
0264-7520-20DEXTROSE250 mL in 1 CONTAINERSOLUTION25012
0264-7520-20DEXTROSE24 in 1 CASESOLUTION2412

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-7520-00ML - Milliliter0264-7520a5fb9b2d-f1d1-408f-87f6-c0dee786d5e112012-07-24
0264-7520-10ML - Milliliter0264-7520d97e3033-155f-435c-afe9-ef7c85fdc0ce12012-07-24
0264-7520-20ML - Milliliter0264-752081a2c13c-032b-416e-8904-7828d462c9c312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROSEACTIVE INGREDIENTIY9XDZ35W2DEXTROSE SOLUTION [B. BRAUN MEDICAL INC.]7
DEXTROSEACTIVE MOIETYIY9XDZ35W2DEXTROSE SOLUTION [B. BRAUN MEDICAL INC.]7
WATERINACTIVE INGREDIENT059QF0KO0RDEXTROSE SOLUTION [B. BRAUN MEDICAL INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-7520DEXTROSE SOLUTION [B. BRAUN MEDICAL INC.]12Current NDC, Legacy NDC, 6 package rows20240316_085614c7-ada4-4e2c-87c0-c9bc2f18365a.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
DextroseDEXTROSEB. Braun Medical Inc.8ccb10fe-75a5-440b-8cd4-b11f4e98f7b02024-12-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 019626
application number: NDA019626
DEXTROSEDEXTROSEB. Braun Medical Inc.085614c7-ada4-4e2c-87c0-c9bc2f18365a2024-03-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 019626
application number: NDA019626
ndc (product): 0264-7520

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1795481dextrose 10 % in 1000 ML InjectionPSN085614c7-ada4-4e2c-87c0-c9bc2f18365a12
1795480dextrose 10 % in 250 ML InjectionPSN085614c7-ada4-4e2c-87c0-c9bc2f18365a12
1795477dextrose 10 % in 500 ML InjectionPSN085614c7-ada4-4e2c-87c0-c9bc2f18365a12
1795612dextrose 5 % in 1000 ML InjectionPSN085614c7-ada4-4e2c-87c0-c9bc2f18365a12
1795610dextrose 5 % in 250 ML InjectionPSN085614c7-ada4-4e2c-87c0-c9bc2f18365a12
1795607dextrose 5 % in 500 ML InjectionPSN085614c7-ada4-4e2c-87c0-c9bc2f18365a12
17954811000 ML glucose 100 MG/ML InjectionSCD085614c7-ada4-4e2c-87c0-c9bc2f18365a12
17956121000 ML glucose 50 MG/ML InjectionSCD085614c7-ada4-4e2c-87c0-c9bc2f18365a12
1795480250 ML glucose 100 MG/ML InjectionSCD085614c7-ada4-4e2c-87c0-c9bc2f18365a12
1795610250 ML glucose 50 MG/ML InjectionSCD085614c7-ada4-4e2c-87c0-c9bc2f18365a12
1795477500 ML glucose 100 MG/ML InjectionSCD085614c7-ada4-4e2c-87c0-c9bc2f18365a12
1795607500 ML glucose 50 MG/ML InjectionSCD085614c7-ada4-4e2c-87c0-c9bc2f18365a12
1795481dextrose 10 % per 1000 ML InjectionSY085614c7-ada4-4e2c-87c0-c9bc2f18365a12
1795480dextrose 10 % per 250 ML InjectionSY085614c7-ada4-4e2c-87c0-c9bc2f18365a12
1795477dextrose 10 % per 500 ML InjectionSY085614c7-ada4-4e2c-87c0-c9bc2f18365a12
1795612dextrose 5 % per 1000 ML InjectionSY085614c7-ada4-4e2c-87c0-c9bc2f18365a12
1795610dextrose 5 % per 250 ML InjectionSY085614c7-ada4-4e2c-87c0-c9bc2f18365a12
1795607dextrose 5 % per 500 ML InjectionSY085614c7-ada4-4e2c-87c0-c9bc2f18365a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-7520-000026475200012 CONTAINER in 1 CASE (0264-7520-00) / 1000 mL in 1 CONTAINER12 container1988-02-020000-00-00NoNoCurrent
0264-7520-100026475201024 CONTAINER in 1 CASE (0264-7520-10) / 500 mL in 1 CONTAINER24 container1988-02-020000-00-00NoNoCurrent
0264-7520-200026475202024 CONTAINER in 1 CASE (0264-7520-20) / 250 mL in 1 CONTAINER24 container1988-02-020000-00-00NoNoCurrent