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 1 of 10 · 199 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MysolinePRIMIDONEBausch Health US, LLCaf593171-dabb-4ea3-b44c-89ed457b2c462026-09-10Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
PrimidonePRIMIDONENCS HealthCare of KY, LLC dba Vangard Labs14f9aee1-4d3e-45e0-ad5c-70bd98667adc2026-09-01Warnings, Adverse reactionsExact identifier
rxcui: 198150
unii: 13AFD7670Q
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
PrimidonePRIMIDONEBryant Ranch Prepack93b4b34c-6dba-4aec-b98e-b2b18feb86a92026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 198150
unii: 13AFD7670Q
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
Humalog KwikPenINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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