FDA.reportPublic FDA data

NDC 50090-2130-01 - 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
50090-2130
Requested NDC
50090-2130-01
Package NDCs from labels
50090-2130-1, 50090-2130-2, 50090-2130-0, 50090-2130-01
Manufacturer
A-S Medication Solutions
Effective date
2026-08-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lamotrigine - A-S Medication SolutionsA-S Medication Solutions2026-08-05HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-2130-02023-02-07These highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE Tablets, for oral use Initial U.S. Approval: 1994
50090-2130-02023-02-07These highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE Tablets, for oral use Initial U.S. Approval: 1994
50090-2130-12023-02-07These highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE Tablets, for oral use Initial U.S. Approval: 1994
50090-2130-12023-02-07These highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE Tablets, for oral use Initial U.S. Approval: 1994
50090-2130-22023-02-07These highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE Tablets, for oral use Initial U.S. Approval: 1994
50090-2130-22023-02-07These highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE Tablets, for oral use Initial U.S. Approval: 1994
50090-2130-02023-01-30These highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE Tablets, for oral use Initial U.S. Approval: 1994
50090-2130-02023-01-30These highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE Tablets, for oral use Initial U.S. Approval: 1994
50090-2130-12023-01-30These highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE Tablets, for oral use Initial U.S. Approval: 1994
50090-2130-12023-01-30These highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE Tablets, for oral use Initial U.S. Approval: 1994
50090-2130-22023-01-30These highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE Tablets, for oral use Initial U.S. Approval: 1994
50090-2130-22023-01-30These highlights do not include all the information needed to use LAMOTRIGINE TABLETS safely and effectively. See full prescribing information for LAMOTRIGINE TABLETS. LAMOTRIGINE Tablets, for oral use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2130-0Lamotrigine30 in 1 BOTTLETABLET3028
50090-2130-1Lamotrigine60 in 1 BOTTLETABLET6028
50090-2130-2Lamotrigine90 in 1 BOTTLETABLET9028

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2130LAMOTRIGINE TABLET [A-S MEDICATION SOLUTIONS]25Current NDC, Legacy NDC, 3 package rows20240824_6139a858-700c-4eb9-9f84-99d280bde326.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2130-0EA - Each50090-2130df7b6383-9180-4c42-b360-2fb86a6c90d312019-02-13
50090-2130-1EA - Each50090-2130ec7d0268-1c90-4404-8535-4e21075dd34012018-11-06
50090-2130-2EA - Each50090-21300d1324f2-d261-4fee-96f1-4318b71d8d1912019-02-13

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 · 167 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
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
rxcui: 198427
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
application number: ANDA090170
ndc (package): 50090-2130-1
ndc (package): 50090-2129-2
ndc (package): 50090-2129-0
ndc (package): 50090-2131-0
ndc (package): 50090-2130-0
ndc (package): 50090-2131-1
ndc (package): 50090-2129-1
ndc (package): 50090-2130-2
ndc (product): 50090-2130
ndc (product): 50090-2129
ndc (product): 50090-2131
ndc11 (package): 50090213001
rxcui: 282401
rxcui: 198428
rxcui: 198427
spl id: 36f4048a-f5fd-42dc-8a01-6078b47f624f
spl set id: 6139a858-700c-4eb9-9f84-99d280bde326
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
rxcui: 282401
rxcui: 198427
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
rxcui: 198427
unii: U3H27498KS
LamotrigineLAMOTRIGINEREMEDYREPACK INC.d1691a60-ff0a-4755-b445-1d78309d5af02026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090170
rxcui: 198428
unii: U3H27498KS
LamotrigineLAMOTRIGINEREMEDYREPACK INC.346f8af3-b850-48e4-bd6e-82ecafca86d22026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090170
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEREMEDYREPACK INC.f5761818-4eaf-4335-a77a-9cd703278ded2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090170
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.