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 5 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Steritalc 2gTALCNovatech SAc94e51d9-beef-4b06-e053-2a95a90a754a2025-06-25Warnings, Adverse reactionsExact identifier
unii: 7SEV7J4R1U
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
SENSITIVE POCKET SUNSENSITIVE POCKET SUNShantou Oushiya Biotechnology Co., Ltd36ac412f-e31f-6906-e063-6394a90a4a3d2025-06-14WarningsExact identifier
unii: 7SEV7J4R1U
PrimidonePRIMIDONEPD-Rx Pharmaceuticals, Inc.0193c0a4-f593-609c-e063-6294a90aaa682025-06-10Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PrimidonePRIMIDONENorthStar Rx LLC182a424b-d142-48c9-996b-059c0885f5282025-05-21Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
PRIMIDONEPRIMIDONEDIRECT RXc20f803c-e965-9dd8-e053-2995a90a92ba2025-01-17Warnings, Adverse reactionsExact identifier
rxcui: 198150
unii: 13AFD7670Q
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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