FDA.reportPublic FDA data

DEXTROSE

Product NDC
51662-1306
Requested package NDC
51662-1306-1
11-digit product format
516621306
Labeler code
51662
Product ID
51662-1306_9f932738-bc2e-0cac-e053-2a95a90aa47e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXTROSE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA016367
Marketing category
NDA
Marketing start
2018-10-06
Marketing end
0000-00-00
Substance
DEXTROSE MONOHYDRATE
Active strength
5 g/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51662-130651662-1306-1IInactivated by FDA2026-07-31

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
N016367-002DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N016367-002AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N016367-002AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DextroseDEXTROSE MONOHYDRATEICU Medical, Inc.8b25b7e0-703e-4b43-a4eb-52863511602d2025-11-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 016367
application number: NDA016367

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51662-1306-12025-01-30C16284748780-19d75b9d0-63fd-f424-e053-dadaa90a57ce5% DEXTROSE INJECTION
51662-1306-12020-02-07C16284748780-19d75b9d0-63fd-f424-e053-dadaa90a57ce5% DEXTROSE INJECTION
51662-1306-12020-01-31C16284748780-19d75b9d0-63fd-f424-e053-dadaa90a57ce5% DEXTROSE INJECTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1306-1DEXTROSE1 in 1 POUCHINJECTION, SOLUTION14
51662-1306-1DEXTROSE100 mL in 1 BAGINJECTION, SOLUTION1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1306DEXTROSE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]4Legacy NDC, 2 package rows20200228_7790c2ce-2f46-7c4d-e053-2991aa0a7eda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1795609dextrose 5 % in 100 ML InjectionPSN7790c2ce-2f46-7c4d-e053-2991aa0a7eda4
1795610dextrose 5 % in 250 ML InjectionPSN7790c2ce-2f46-7c4d-e053-2991aa0a7eda4
1795609100 ML glucose 50 MG/ML InjectionSCD7790c2ce-2f46-7c4d-e053-2991aa0a7eda4
1795610250 ML glucose 50 MG/ML InjectionSCD7790c2ce-2f46-7c4d-e053-2991aa0a7eda4
1795609dextrose 5 % per 100 ML InjectionSY7790c2ce-2f46-7c4d-e053-2991aa0a7eda4
1795610dextrose 5 % per 250 ML InjectionSY7790c2ce-2f46-7c4d-e053-2991aa0a7eda4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1306-1516621306011 BAG in 1 POUCH (51662-1306-1) > 100 mL in 1 BAG1 bag2018-10-060000-00-00NoNoCurrent