FDA.reportPublic FDA data

NDC 44946-1009-3 - Ludent

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
44946-1009
Requested NDC
44946-1009-3
Package NDCs from labels
44946-1009-3, 44946-1009-9
Manufacturer
A-S Medication Solutions
Effective date
2018-08-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ludent - A-S Medication SolutionsA-S Medication Solutions2018-08-31DIETARY SUPPLEMENT
Ludent - Sancilio & Company IncSancilio & Company Inc2018-02-06DIETARY SUPPLEMENT
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44946-1009-3Ludent120 in 1 BOTTLETABLET, CHEWABLE1204
44946-1009-3Ludent24 in 1 BOXTABLET, CHEWABLE244
44946-1009-9Ludent12 in 1 BOXTABLET, CHEWABLE124
44946-1009-9Ludent1000 in 1 BOTTLETABLET, CHEWABLE10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44946-1009LUDENT (SODIUM FLUORIDE) TABLET, CHEWABLE [SANCILIO & COMPANY INC]44 package rows20180210_4a63d24a-4d80-46a5-9a8c-f8949dfc382a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44946-1009-3EA - Each44946-10092cd8bfae-f7a4-455e-8fcb-90ca50b22fd312012-07-24
44946-1009-9EA - Each44946-10095f96327a-ec27-41a1-8528-c7276660d63812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7LUDENT (SODIUM FLUORIDE) TABLET, CHEWABLE [SANCILIO & COMPANY INC]1
Fluoride IonACTIVE MOIETYQ80VPU408OLUDENT (SODIUM FLUORIDE) TABLET, CHEWABLE [SANCILIO & COMPANY INC]1

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 53 of 58 · 1,157 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Natrum FluoratumNATRUM FLUORATUMHahnemann Laboratories, INC.e54bdb28-890b-4869-e053-2995a90a8efd2022-08-02Exact identifier
unii: 8ZYQ1474W7
ACD Blood-Pack Units (PL 146 PLASTIC)ANTICOAGULANT CITRATE DEXTROSE (ACD)Fenwal, Inc.ba894daa-688e-4a9e-bd74-e71797f951bb2022-04-27Exact identifier
unii: XF417D3PSL
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.22805f0d-ba58-41ea-b245-19980abcda222022-02-11Exact identifier
unii: XF417D3PSL
Iris 60 Second APFSODIUM FLUORIDEBenco Dental5fa57e34-5827-4d37-a5dc-965750e5be502022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Iris 60 Second APFSODIUM FLUORIDEBenco Dental6a0f889d-5f27-496f-b830-d778ee867ade2022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Iris 60 Second APFSODIUM FLUORIDEBenco Dental8f5d420b-3348-4002-9a09-b05e8cbb35c92022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Iris 60 Second APFSODIUM FLUORIDEBenco Dentalc93f67f5-9833-4a7a-a67a-49a51843e68d2022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Iris 60 Second APFSODIUM FLUORIDEBenco Dentald5658bf8-3a13-4d8b-b727-5f15759195712022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Burkhart Neutral pHSODIUM FLUORIDEBurkhart Dental Supply Inca7259222-4ee1-42b2-8beb-3f29a5eb29092022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Burkhart Neutral pHSODIUM FLUORIDEBurkhart Dental Supply Inc0fb4d584-36e8-4db7-b72e-04608580dacd2022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc2531ad94-b229-4212-a7a3-f793567a06b62022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc804e7850-1952-4e86-804e-d800ee6e7b502022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc87b3b8b8-780f-492d-bd75-b005edd55baa2022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc79fa0a42-bb69-49db-9997-1679a75bac262022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Incd7422939-c28e-4bda-b679-81abcc8c36e22022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc192c4e46-0bfd-4f48-901c-ce4f09f91e3e2022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc5ef9652f-4d99-493d-97ee-9807c6f391822022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc8d1997c0-4f61-46b5-954e-620d521d3fba2022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc9cbfd85a-a930-4a4b-a362-b142f6312c592022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc26b1f8ab-3540-4c3f-95ab-e9cb1c5cee972022-01-25WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.