Dextrose

Product NDC
0264-1510
11-digit product format
002641510
Labeler code
0264
Product ID
0264-1510_638a41c3-0f07-4d1a-bb4e-1bab16e61266
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextrose
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
NDA016730
Marketing category
NDA
Marketing start
1973-12-21
Substance
DEXTROSE MONOHYDRATE
Active strength
50 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N016730-001DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N016730-002DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N016730-001AP
N016730-002AP

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N016730-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N016730-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N016730-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016730-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016730-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016730-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N016730-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016730-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016730-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016730-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016730-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016730-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016730-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016730-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016730-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016730-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016730-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016730-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016730-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016730-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016730-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N016730-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016730-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016730-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016730-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016730-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016730-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016730-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N016730-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N016730-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016730-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016730-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N016730-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N016730-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N016730-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N016730-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N016730-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N016730-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N016730-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N016730-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N016730-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N016730-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N016730-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016730-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016730-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016730-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N016730-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016730-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016730-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016730-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016730-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016730-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016730-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016730-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016730-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016730-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016730-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016730-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016730-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016730-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016730-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N016730-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016730-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016730-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016730-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016730-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016730-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016730-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N016730-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N016730-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016730-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016730-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N016730-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N016730-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N016730-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N016730-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N016730-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N016730-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N016730-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N016730-002AP1bb7c543d1eb4…

Additional Listing Data#

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

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1795609Internal RxNorm lookup
1795616Internal RxNorm lookup
1795618Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
60b6d7c3-0164-46c9-aa38-b5aa1c31a5d5Available 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
0264-1510-31Dextrose50 mL in 1 CONTAINERINJECTION, SOLUTION5011
0264-1510-31Dextrose84 in 1 CASEINJECTION, SOLUTION8411
0264-1510-32Dextrose100 mL in 1 CONTAINERINJECTION, SOLUTION10011
0264-1510-32Dextrose64 in 1 CASEINJECTION, SOLUTION6411
0264-1510-36Dextrose116 in 1 CASEINJECTION, SOLUTION11611
0264-1510-36Dextrose25 mL in 1 CONTAINERINJECTION, SOLUTION2511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-1510-31ML - Milliliter0264-1510da9ce8db-e96f-4985-8768-846e123bd56c12012-07-24
0264-1510-32ML - Milliliter0264-1510a7cc77b1-ac0e-4f55-a9d7-dbf91648803412012-07-24
0264-1510-36ML - Milliliter0264-1510ed917a73-d8e6-4def-bb80-bffb0ea90a6f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROSE MONOHYDRATEACTIVE INGREDIENTLX22YL083GDEXTROSE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]4
ANHYDROUS DEXTROSEACTIVE MOIETY5SL0G7R0OKDEXTROSE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RDEXTROSE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-1510DEXTROSE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]7Current NDC, Legacy NDC, 6 package rows20240110_60b6d7c3-0164-46c9-aa38-b5aa1c31a5d5.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DextroseDEXTROSEB. Braun Medical Inc.60b6d7c3-0164-46c9-aa38-b5aa1c31a5d52026-05-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 016730
application number: NDA016730
ndc (product): 0264-1510

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1795609dextrose 5 % in 100 ML InjectionPSN60b6d7c3-0164-46c9-aa38-b5aa1c31a5d511
1795618dextrose 5 % in 25 ML InjectionPSN60b6d7c3-0164-46c9-aa38-b5aa1c31a5d511
1795616dextrose 5 % in 50 ML InjectionPSN60b6d7c3-0164-46c9-aa38-b5aa1c31a5d511
1795609100 ML glucose 50 MG/ML InjectionSCD60b6d7c3-0164-46c9-aa38-b5aa1c31a5d511
179561825 ML glucose 50 MG/ML InjectionSCD60b6d7c3-0164-46c9-aa38-b5aa1c31a5d511
179561650 ML glucose 50 MG/ML InjectionSCD60b6d7c3-0164-46c9-aa38-b5aa1c31a5d511
1795609dextrose 5 % per 100 ML InjectionSY60b6d7c3-0164-46c9-aa38-b5aa1c31a5d511
1795618dextrose 5 % per 25 ML InjectionSY60b6d7c3-0164-46c9-aa38-b5aa1c31a5d511
1795616dextrose 5 % per 50 ML InjectionSY60b6d7c3-0164-46c9-aa38-b5aa1c31a5d511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-1510-310026415103184 CONTAINER in 1 CASE (0264-1510-31) / 50 mL in 1 CONTAINER84 container1973-12-210000-00-00NoNoCurrent
0264-1510-320026415103264 CONTAINER in 1 CASE (0264-1510-32) / 100 mL in 1 CONTAINER64 container1973-12-210000-00-00NoNoCurrent
0264-1510-3600264151036116 CONTAINER in 1 CASE (0264-1510-36) / 25 mL in 1 CONTAINER116 container1973-12-210000-00-00NoNoCurrent