FDA.reportPublic FDA data

NDC 55111-221-79 - 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
55111-221
Requested NDC
55111-221-79
Package NDCs from labels
55111-221-30, 55111-221-60, 55111-221-01, 55111-221-05, 55111-221-79, 55111-221-78
Manufacturer
Dr.Reddy's Laboratories Limited | Dr.Reddy's Laboratories Limited FTO-3
Effective date
2024-12-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lamotrigine - Dr.Reddy's Laboratories Limited | Dr.Reddy's Laboratories Limited FTO-3Dr.Reddy's Laboratories Limited | Dr.Reddy's Laboratories Limited FTO-32024-12-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-221-01Lamotrigine100 in 1 BOTTLETABLET10011
55111-221-05Lamotrigine500 in 1 BOTTLETABLET50011
55111-221-30Lamotrigine30 in 1 BOTTLETABLET3011
55111-221-60Lamotrigine60 in 1 BOTTLETABLET6011
55111-221-78Lamotrigine10 in 1 CARTONTABLET1011
55111-221-79Lamotrigine10 in 1 BLISTER PACKTABLET1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-221LAMOTRIGINE TABLET [DR.REDDY'S LABORATORIES LIMITED]11Current NDC, Legacy NDC, 6 package rows20241222_44670496-41ea-36a1-c435-32e359766a74.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-221-01EA - Each55111-221a62522b4-7c51-4592-9529-3e11ad0420f812012-07-24
55111-221-05EA - Each55111-221f0476f37-8011-483e-891a-fee540fe326312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [DR.REDDY'S LABORATORIES LIMITED]9
LamotrigineACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [DR.REDDY'S LABORATORIES LIMITED]9

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 5 of 7 · 123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamotrigineLAMOTRIGINEBryant Ranch Prepack812bc0d8-bb31-4fb1-9f4a-f8c17cbc769c2025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198429
unii: U3H27498KS
LamotrigineLAMOTRIGINEBryant Ranch Prepack53774022-ea0c-42a9-a720-dc755c77b8512025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198427
unii: U3H27498KS
LamotrigineLAMOTRIGINECoupler LLC3dfdcc2d-b7c5-7abf-e063-6394a90a24a62025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
unii: U3H27498KS
LamotrigineLAMOTRIGINEBryant Ranch Prepackd33c4293-347c-49a1-9d98-f291c3dab6da2025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198428
unii: U3H27498KS
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
LamotrigineLAMOTRIGINEJubilant Cadista Pharmacuticals Inc.0b0f0209-edbd-46f3-9bed-762cbea0d7372025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
unii: U3H27498KS
Steritalc 2gTALCNovatech SAc94e51d9-beef-4b06-e053-2a95a90a754a2025-06-25Warnings, Adverse reactionsExact identifier
unii: 7SEV7J4R1U
LamotrigineLAMOTRIGINEBryant Ranch Prepack2cf33586-e48a-4b4e-b14b-33de2be63c1d2025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
unii: U3H27498KS
LamotrigineLAMOTRIGINEBryant Ranch Prepack4bbc140c-6092-416d-865d-49b89c5ecdd02025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198427
unii: U3H27498KS
LamotrigineLAMOTRIGINEBryant Ranch Prepackcf03f130-067f-401c-8501-0d78a989a3192025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198429
unii: U3H27498KS
SENSITIVE POCKET SUNSENSITIVE POCKET SUNShantou Oushiya Biotechnology Co., Ltd36ac412f-e31f-6906-e063-6394a90a4a3d2025-06-14WarningsExact identifier
unii: 7SEV7J4R1U
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
LamotrigineLAMOTRIGINENuCare Pharmaceuticals,Inc.065e97c9-3c5f-16e6-e063-6294a90a13fc2025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198427
unii: U3H27498KS
Lamotrigine ERLAMOTRIGINE ERDirect_Rxfaccacb7-65f1-cb00-e053-6394a90a9fcb2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS
LAMOTRIGINELAMOTRIGINEDIRECT RXa835b697-2beb-1ba8-e053-2995a90a470c2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
unii: U3H27498KS
A-18CEIBA PENTANDRA SEED, POWDERED CELLULOSE, AND BOMBYX MORI FIBERDNA Labs, Inc.ba92d784-26be-46da-8efe-ec121fb64b8d2025-01-09WarningsExact identifier
unii: SMD1X3XO9M
LamotrigineLAMOTRIGINEAdvanced Rx Pharmacy of Tennessee, LLCf7a86237-ece4-7cc4-e053-6294a90a13082024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 282401
unii: U3H27498KS
LamotrigineLAMOTRIGINEDr.Reddy's Laboratories Limited44670496-41ea-36a1-c435-32e359766a742024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076708
ndc (package): 55111-222-30
ndc (package): 55111-221-05
ndc (package): 55111-223-30
ndc (package): 55111-223-01
ndc (package): 55111-220-79
ndc (package): 55111-220-60
ndc (package): 55111-221-60
ndc (package): 55111-221-78
ndc (package): 55111-220-30
ndc (package): 55111-221-01
ndc (package): 55111-222-05
ndc (package): 55111-223-79
ndc (package): 55111-220-01
ndc (package): 55111-223-60
ndc (package): 55111-222-01
ndc (package): 55111-220-05
ndc (package): 55111-223-05
ndc (package): 55111-221-30
ndc (package): 55111-222-78
ndc (package): 55111-222-79
ndc (package): 55111-223-78
ndc (package): 55111-220-78
ndc (package): 55111-222-60
ndc (package): 55111-221-79
ndc (product): 55111-220
ndc (product): 55111-223
ndc (product): 55111-221
ndc (product): 55111-222
ndc11 (package): 55111022179
rxcui: 282401
rxcui: 198428
rxcui: 198427
rxcui: 198429
spl id: b59e510e-d6aa-6f6b-53ef-3152aeedced7
spl set id: 44670496-41ea-36a1-c435-32e359766a74
unii: U3H27498KS
LamotrigineLAMOTIRIGINEZydus Lifesciences Limitedecb7a528-699f-4e51-9887-dee60456da2f2024-11-30Exact identifier
unii: U3H27498KS
LamotrigineLAMOTRIGINEAlembic Pharmaceuticals Limitedfaee013c-cad2-4abb-904c-e6ff79ba778c2024-10-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U3H27498KS

Reported adverse events (FAERS/openFDA)#

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