FDA.reportPublic FDA data

NDC 50268-687-11 - 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
50268-687
Requested NDC
50268-687-11
Package NDCs from labels
50268-687-11, 50268-687-15
Manufacturer
AvPAK
Effective date
2025-11-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Primidone - AvPAKAvPAK2025-11-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-687-11Primidone1 in 1 BLISTER PACKTABLET114
50268-687-15Primidone50 in 1 BOX, UNIT-DOSETABLET5014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-687PRIMIDONE TABLET [AVPAK]12Current NDC, Legacy NDC, 2 package rows20240110_a90d5ba6-4170-0b97-5ae3-fc707c9e4f1b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-687-11EA - Each50268-687d9a41259-bf91-4100-bb9a-6bd0f218bbb512015-05-05
50268-687-15EA - Each50268-6874dbd7603-b10c-4af9-9bfb-e7b851dfcd0a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRIMIDONEACTIVE INGREDIENT13AFD7670QPRIMIDONE TABLET [AVPAK]8
PRIMIDONEACTIVE MOIETY13AFD7670QPRIMIDONE TABLET [AVPAK]8
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UPRIMIDONE TABLET [AVPAK]8
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XPRIMIDONE TABLET [AVPAK]8
Magnesium StearateINACTIVE INGREDIENT70097M6I30PRIMIDONE TABLET [AVPAK]8
Methylcellulose (100 Cps)INACTIVE INGREDIENT4GFU244C4JPRIMIDONE TABLET [AVPAK]8
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JPRIMIDONE TABLET [AVPAK]8
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2PRIMIDONE TABLET [AVPAK]8
Starch, CornINACTIVE INGREDIENTO8232NY3SJPRIMIDONE TABLET [AVPAK]8

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 3 · 41 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
PrimidonePRIMIDONEBryant Ranch Prepack93b4b34c-6dba-4aec-b98e-b2b18feb86a92026-06-24Warnings, Adverse reactionsExact identifier
application number: ANDA040866
rxcui: 198150
unii: 13AFD7670Q
PrimidonePRIMIDONEAvKAREe7a50a67-9653-463e-8c85-315b53f460c82026-05-13Warnings, Adverse reactionsExact identifier
application number: ANDA040866
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
PrimidonePRIMIDONEAmneal Pharmaceuticals of New York LLC3cdc361a-5558-4341-ad40-f8bc29b4f1ce2026-04-02Warnings, Adverse reactionsExact identifier
application number: ANDA040866
ndc (product): 53746-544
ndc (product): 53746-545
rxcui: 96304
rxcui: 198150
spl id: 574c0bff-04c5-41f0-8d10-315a824d8efd
spl set id: 3cdc361a-5558-4341-ad40-f8bc29b4f1ce
unii: 13AFD7670Q
PrimidonePRIMIDONEActavis Pharma, Inc.ae0fa704-818e-4423-8e3a-6cc3390cdd7d2026-02-01Warnings, Adverse reactionsExact identifier
rxcui: 96304
unii: 13AFD7670Q
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
PrimidonePRIMIDONEAdvagen Pharma Limitedb3b94d2e-6a64-45b7-b0cb-0fde689240d82026-01-13Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
PrimidonePRIMIDONEProficient Rx LPdb761e34-8573-4f96-872c-e851b3004e5e2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
PrimidonePRIMIDONEChartwell RX, LLC4a8e309f-d89e-4b1a-abb2-856a66ebbff92025-12-11Warnings, Adverse reactionsExact identifier
rxcui: 198150
unii: 13AFD7670Q
PrimidonePRIMIDONEAvPAKa90d5ba6-4170-0b97-5ae3-fc707c9e4f1b2025-11-05Warnings, Adverse reactionsExact identifier
application number: ANDA040866
ndc (package): 50268-686-15
ndc (package): 50268-687-11
ndc (package): 50268-686-11
ndc (package): 50268-687-15
ndc (product): 50268-687
ndc (product): 50268-686
ndc11 (package): 50268068711
rxcui: 96304
rxcui: 198150
spl id: 42dc4ff9-003f-d362-e063-6394a90ad6f9
spl set id: a90d5ba6-4170-0b97-5ae3-fc707c9e4f1b
unii: 13AFD7670Q
PrimidonePRIMIDONEPD-Rx Pharmaceuticals, Inc.6046e4e9-0c1e-4d1f-85fa-d2ce25c5dc342025-10-20Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
TRIMO SANOXYQUINOLINE SULFATE AND SODIUM LAURYL SULFATECooperSurgical, Inc.1e4a1caa-e6ba-44ef-8347-07e6385a7c9e2025-09-03WarningsExact identifier
unii: 368GB5141J
PrimidonePRIMIDONEPD-Rx Pharmaceuticals, Inc.0193c0a4-f593-609c-e063-6294a90aaa682025-06-10Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
PrimidonePRIMIDONENorthStar Rx LLC182a424b-d142-48c9-996b-059c0885f5282025-05-21Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
PRIMIDONEPRIMIDONEDIRECT RXc20f803c-e965-9dd8-e053-2995a90a92ba2025-01-17Warnings, Adverse reactionsExact identifier
rxcui: 198150
unii: 13AFD7670Q

Reported adverse events (FAERS/openFDA)#

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