FDA.reportPublic FDA data

NDC 68084-319-11 - Lamotrigine

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
68084-319
Requested NDC
68084-319-11
Package NDCs from labels
68084-319-11, 68084-319-01
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-09-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lamotrigine - Cardinal Health 107, LLCCardinal Health 107, LLC2026-09-04HUMAN PRESCRIPTION DRUG LABEL
Lamotrigine - American Health PackagingAmerican Health Packaging2026-07-30HUMAN PRESCRIPTION DRUG LABEL
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
68084-319-01Lamotrigine100 in 1 BOX, UNIT-DOSETABLET10016
68084-319-11Lamotrigine1 in 1 BLISTER PACKTABLET116

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-319LAMOTRIGINE TABLET [AMERICAN HEALTH PACKAGING]16Current NDC, Legacy NDC, 2 package rows20241122_35aa48a2-2ce6-4a6e-bf5a-1bc6111d1234.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-319-01EA - Each68084-31925cc8be4-ac17-41f5-a6f1-ebc8478a064612012-07-24
68084-319-11EA - Each68084-319e8896f43-1ca0-4aea-84c7-8195d54ff48012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [CARDINAL HEALTH]8
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [CARDINAL HEALTH]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [CARDINAL HEALTH]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [CARDINAL HEALTH]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [CARDINAL HEALTH]8
POVIDONESINACTIVE INGREDIENTFZ989GH94ELAMOTRIGINE TABLET [CARDINAL HEALTH]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE TABLET [CARDINAL HEALTH]8
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [AMERICAN HEALTH PACKAGING]7
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [AMERICAN HEALTH PACKAGING]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [AMERICAN HEALTH PACKAGING]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [AMERICAN HEALTH PACKAGING]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [AMERICAN HEALTH PACKAGING]7
POVIDONESINACTIVE INGREDIENTFZ989GH94ELAMOTRIGINE TABLET [AMERICAN HEALTH PACKAGING]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE TABLET [AMERICAN HEALTH PACKAGING]7

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 9 · 170 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
LamotrigineLAMOTRIGINECardinal Health 107, LLCbeb24a4f-ab0b-435a-b60b-2b8d565ecd752026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077633
rxcui: 282401
rxcui: 198427
unii: U3H27498KS
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
LamotrigineLAMOTRIGINECardinal Health 107, LLC20e156df-a2b6-4710-b526-0419cd17dd332026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077633
ndc (package): 55154-2065-0
ndc (product): 55154-2065
rxcui: 198427
spl id: cc4537ab-8839-4f4e-a232-0cf7a52d2f39
spl set id: 20e156df-a2b6-4710-b526-0419cd17dd33
unii: U3H27498KS
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
LamotrigineLAMOTRIGINEAmneal Pharmaceuticals LLC0833d3df-2df1-4abd-abe0-7fb2c0253c802026-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEA-S Medication Solutions6139a858-700c-4eb9-9f84-99d280bde3262026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
unii: U3H27498KS
LamotrigineLAMOTRIGINEDr. Reddys Laboratories Inc.54ea1ec3-876b-4d3a-a92b-1a6d70951de02026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LAMOTRIGINELAMOTRIGINEGolden State Medical Supply, Inc.57f04b9b-06cd-8044-e063-6394a90ae7332026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEAmerican Health Packaging35aa48a2-2ce6-4a6e-bf5a-1bc6111d12342026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077633
ndc (package): 68084-319-01
ndc (package): 68084-318-01
ndc (package): 68084-318-11
ndc (package): 68084-319-11
ndc (product): 68084-318
ndc (product): 68084-319
ndc11 (package): 68084031911
rxcui: 282401
rxcui: 198427
spl id: 57d4fcd2-5f9e-1832-e063-6394a90a63f2
spl set id: 35aa48a2-2ce6-4a6e-bf5a-1bc6111d1234
unii: U3H27498KS
LAMOTRIGINELAMOTRIGINEREMEDYREPACK INC.50d46278-636a-470e-afcc-d3c8bd844e462026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198427
unii: U3H27498KS
LamotrigineLAMOTRIGINEAlembic Pharmaceuticals Inc.60958229-5b5f-49e2-97f4-a8722138f7ce2026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
LAMOTRIGINELAMOTRIGINEREMEDYREPACK INC.1d7c2d52-a78e-4508-8853-ba306cdeeaba2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
unii: U3H27498KS
LamotrigineLAMOTRIGINEREMEDYREPACK INC.15d801a0-f0a5-40c1-bc88-d5ba9a02c6962026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077633
rxcui: 198427
unii: U3H27498KS
LamotrigineLAMOTRIGINEREMEDYREPACK INC.d1691a60-ff0a-4755-b445-1d78309d5af02026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198428
unii: U3H27498KS
LamotrigineLAMOTRIGINEREMEDYREPACK INC.346f8af3-b850-48e4-bd6e-82ecafca86d22026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEREMEDYREPACK INC.f5761818-4eaf-4335-a77a-9cd703278ded2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198427
unii: U3H27498KS
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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