FDA.reportPublic FDA data

NDC 68084-203-11 - 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
68084-203
Requested NDC
68084-203-11
Package NDCs from labels
68084-203-11, 68084-203-01
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
68084-203-01Primidone100 in 1 BOX, UNIT-DOSETABLET10011
68084-203-11Primidone1 in 1 BLISTER PACKTABLET111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-203PRIMIDONE 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
68084-203-01EA - Each68084-2031d1ca8ea-291e-4ef0-bc80-894a4ac837de12012-07-24
68084-203-11EA - Each68084-20362bb6734-fc38-4abc-a9ba-928607015f0912012-07-24

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 1 of 2 · 30 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
rxcui: 198150
unii: 13AFD7670Q
PrimidonePRIMIDONEAvKAREe7a50a67-9653-463e-8c85-315b53f460c82026-05-13Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
PrimidonePRIMIDONEAmneal Pharmaceuticals of New York LLC3cdc361a-5558-4341-ad40-f8bc29b4f1ce2026-04-02Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
PrimidonePRIMIDONEActavis Pharma, Inc.ae0fa704-818e-4423-8e3a-6cc3390cdd7d2026-02-01Warnings, Adverse reactionsExact identifier
rxcui: 96304
unii: 13AFD7670Q
PrimidonePRIMIDONEAdvagen Pharma Limitedb3b94d2e-6a64-45b7-b0cb-0fde689240d82026-01-13Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
Southeast Regional 1024SOUTHEAST REGIONALProfessional Complementary Health Formulas7a4ff3cf-6897-4cca-b907-556270642e042026-01-08WarningsExact identifier
unii: 5C5403N26O
Trees 2 1017TREES 2Professional Complementary Health Formulas601c8ffe-35c2-4dcc-a503-7d9b9998e2842026-01-08WarningsExact identifier
unii: 5C5403N26O
PrimidonePRIMIDONEProficient Rx LPdb761e34-8573-4f96-872c-e851b3004e5e2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
PrimidonePRIMIDONEChartwell RX, LLC4a8e309f-d89e-4b1a-abb2-856a66ebbff92025-12-11Warnings, Adverse reactionsExact identifier
application number: ANDA084903
rxcui: 198150
unii: 13AFD7670Q
PrimidonePRIMIDONEAvPAKa90d5ba6-4170-0b97-5ae3-fc707c9e4f1b2025-11-05Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
PrimidonePRIMIDONEPD-Rx Pharmaceuticals, Inc.6046e4e9-0c1e-4d1f-85fa-d2ce25c5dc342025-10-20Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
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
PRIMIDONEPRIMIDONEDIRECT RXc20f803c-e965-9dd8-e053-2995a90a92ba2025-01-17Warnings, Adverse reactionsExact identifier
rxcui: 198150
unii: 13AFD7670Q
PrimidonePRIMIDONEGolden State Medical Supply, Ince4e493bd-94d7-7e5a-e053-2995a90a27062024-12-23Warnings, Adverse reactionsExact identifier
application number: ANDA084903
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
Thyroid TonicACACIA ARABICA, OLEUM OLEA EUROPAEA, SESAME OIL, FUCUS VESICULOSUS 3X, IODIUM, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAGE OIL, CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), HYDROFLUORICUM ACIDUMEnergique, Inc.aeca8e0e-12e6-44d0-a709-401d137f7cf32024-10-31WarningsExact identifier
unii: 5C5403N26O
PrimidonePRIMIDONEAmneal Pharmaceuticals LLC02ba0182-0870-4c0d-a814-a1dc427d47b82024-10-30Warnings, Adverse reactionsExact identifier
rxcui: 96304
rxcui: 198150
unii: 13AFD7670Q
PrimidonePRIMIDONEAmerican Health Packaginga32e0a00-3ba7-47e7-83c6-a7eac5fbdd112024-10-03Warnings, Adverse reactionsExact identifier
application number: ANDA084903
ndc (package): 68084-202-11
ndc (package): 68084-203-11
ndc (package): 68084-203-01
ndc (package): 68084-202-01
ndc (product): 68084-202
ndc (product): 68084-203
ndc11 (package): 68084020311
rxcui: 96304
rxcui: 198150
spl id: 23950268-33a3-8f1e-e063-6394a90a736a
spl set id: a32e0a00-3ba7-47e7-83c6-a7eac5fbdd11
unii: 13AFD7670Q

Reported adverse events (FAERS/openFDA)#

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