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 6 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PrimidonePRIMIDONEGolden State Medical Supply, Ince4e493bd-94d7-7e5a-e053-2995a90a27062024-12-23Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 368GB5141J
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
PrimidonePRIMIDONEAmneal Pharmaceuticals LLC02ba0182-0870-4c0d-a814-a1dc427d47b82024-10-30Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
PrimidonePRIMIDONEAmerican Health Packaginga32e0a00-3ba7-47e7-83c6-a7eac5fbdd112024-10-03Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 368GB5141J
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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