FDA.reportPublic FDA data

NDC 68084-202-11 - 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
68084-202
Requested NDC
68084-202-11
Package NDCs from labels
68084-202-11, 68084-202-01
Manufacturer
American Health Packaging
Effective date
2024-10-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Primidone - American Health PackagingAmerican Health Packaging2024-10-03HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-202-01Primidone100 in 1 BOX, UNIT-DOSETABLET10011
68084-202-11Primidone1 in 1 BLISTER PACKTABLET111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-202PRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]11Current NDC, Legacy NDC, 2 package rows20241004_a32e0a00-3ba7-47e7-83c6-a7eac5fbdd11.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-202-01EA - Each68084-202d6667e7a-52a3-4f32-a547-bf99d3ec7e2112012-07-24
68084-202-11EA - Each68084-202334e5c6a-3b8d-43af-8191-50bca1c87c8112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRIMIDONEACTIVE INGREDIENT13AFD7670QPRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]2
PRIMIDONEACTIVE MOIETY13AFD7670QPRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]2
ACACIAINACTIVE INGREDIENT5C5403N26OPRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]2
METHYLCELLULOSE (400 MPA.S)INACTIVE INGREDIENTO0GN6F9B2YPRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PRIMIDONE TABLET [AMERICAN HEALTH PACKAGING]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 2 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrimidonePRIMIDONECarnegie Pharmaceuticals LLCdc018b1d-72d3-45a2-84ff-cf9499c7ae972024-06-05Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
PrimidonePRIMIDONEBryant Ranch Prepack5067ff85-07f5-424c-b072-6907891e7b4e2024-05-23Warnings, Adverse reactionsExact identifier
rxcui: 198150
unii: 13AFD7670Q
PrimidonePRIMIDONEAphena Pharma Solutions - Tennessee, LLCad8b50e2-e797-4326-a57e-d254da85b6b92024-01-09Warnings, Adverse reactionsExact identifier
application number: ANDA084903
rxcui: 198150
unii: 13AFD7670Q
PrimidonePRIMIDONETruPharma LLC.c60b3a92-4404-4a89-b2c5-c23ff72bedad2023-03-08Warnings, Adverse reactionsExact identifier
unii: 13AFD7670Q
PrimidonePRIMIDONENCS HealthCare of KY, LLC dba Vangard Labs1c56d09c-4224-4875-bb22-e8bfd595d3782023-03-03Warnings, Adverse reactionsExact identifier
rxcui: 198150
unii: 13AFD7670Q
PrimidonePRIMIDONEOxford Pharmaceuticals, LLC439096a4-c5d5-4ad8-be9c-238973a3e2902022-04-05Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
PrimidonePRIMIDONEAphena Pharma Solutions - Tennessee, LLC91de277e-34b8-4ee1-8846-f02aea6260892021-10-15Warnings, Adverse reactionsExact identifier
rxcui: 198150
unii: 13AFD7670Q
PrimidonePRIMIDONEAphena Pharma Solutions - Tennessee, LLC70b93341-ce93-4be5-a782-87c1a26129d72021-08-19Warnings, Adverse reactionsExact identifier
rxcui: 198150
unii: 13AFD7670Q
PrimidonePRIMIDONELannett Company, Inc.a1a817f7-c190-4825-94eb-442f477187e32020-06-11Warnings, Adverse reactionsExact identifier
application number: ANDA084903
ndc (product): 0527-1231
ndc (product): 0527-1301
rxcui: 96304
rxcui: 198150
spl id: 99bd0a67-2742-43dd-9ddc-430b9141c3b1
spl set id: a1a817f7-c190-4825-94eb-442f477187e3
unii: 13AFD7670Q
PrimidonePRIMIDONEDr. Reddy's Laboratories Limiteda4f917f4-2aa2-c3ed-071e-232fa0f125e82010-12-02Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q

Reported adverse events (FAERS/openFDA)#

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