NDC 55111-477-79 - Primidone

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
55111-477
Requested NDC
55111-477-79
Package NDCs from labels
55111-477-30, 55111-477-60, 55111-477-01, 55111-477-05, 55111-477-79, 55111-477-78
Manufacturer
Dr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited - FTO III
Effective date
2010-12-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Primidone Tablets USPDr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited - FTO III2010-12-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-477-01Primidone100 in 1 BOTTLETABLET1003
55111-477-05Primidone500 in 1 BOTTLETABLET5003
55111-477-30Primidone30 in 1 BOTTLETABLET303
55111-477-60Primidone60 in 1 BOTTLETABLET603
55111-477-78Primidone10 in 1 CARTONTABLET103
55111-477-79Primidone10 in 1 BLISTER PACKTABLET103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-477PRIMIDONE TABLET [DR. REDDY'S LABORATORIES LIMITED]3Current NDC, Legacy NDC, 6 package rows20171206_a4f917f4-2aa2-c3ed-071e-232fa0f125e8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-477-01EA - Each55111-4773fd1ea19-94c9-401f-98b6-012c9eee6a1212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
primidoneACTIVE INGREDIENT13AFD7670QPRIMIDONE TABLET [DR. REDDY'S LABORATORIES LTD]2
primidoneACTIVE MOIETY13AFD7670QPRIMIDONE TABLET [DR. REDDY'S LABORATORIES LTD]2
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTPRIMIDONE TABLET [DR. REDDY'S LABORATORIES LTD]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPRIMIDONE TABLET [DR. REDDY'S LABORATORIES LTD]2
magnesium stearateINACTIVE INGREDIENT70097M6I30PRIMIDONE TABLET [DR. REDDY'S LABORATORIES LTD]2
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JPRIMIDONE TABLET [DR. REDDY'S LABORATORIES LTD]2
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2PRIMIDONE TABLET [DR. REDDY'S LABORATORIES LTD]2
talcINACTIVE INGREDIENT7SEV7J4R1UPRIMIDONE TABLET [DR. REDDY'S LABORATORIES LTD]2
waterINACTIVE INGREDIENT059QF0KO0RPRIMIDONE TABLET [DR. REDDY'S LABORATORIES LTD]2

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 4 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PrimidonePRIMIDONEAvPAKa90d5ba6-4170-0b97-5ae3-fc707c9e4f1b2025-11-05Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PrimidonePRIMIDONEPD-Rx Pharmaceuticals, Inc.6046e4e9-0c1e-4d1f-85fa-d2ce25c5dc342025-10-20Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
TRIMO SANOXYQUINOLINE SULFATE AND SODIUM LAURYL SULFATECooperSurgical, Inc.1e4a1caa-e6ba-44ef-8347-07e6385a7c9e2025-09-03WarningsExact identifier
unii: 368GB5141J
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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