RIDAURA

Product NDC
65483-093
11-digit product format
654830093
Labeler code
65483
Product ID
65483-093_6008addc-7f8e-45bb-8aec-54dd54a788ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
auranofin
Dosage form
CAPSULE
Route
ORAL
Labeler
Prometheus Laboratories Inc.
Application
NDA018689
Marketing category
NDA
Marketing start
1985-04-24
Marketing end
0000-00-00
Substance
AURANOFIN
Active strength
3 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ee8d39e4-f907-4d8f-130c-6fceb48ba86aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65483-093-062019-11-13C16284748780-197449f38-be91-f6ea-e053-dbdaa90aa703PRESCRIBING INFORMATION RIDAURA ® Auranofin Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65483-093-06RIDAURA60 in 1 BOTTLECAPSULE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65483-093-06EA - Each65483-093bd6f6a6e-f653-4035-9315-e68e5a2584b312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
auranofinACTIVE INGREDIENT3H04W2810VRIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]3
auranofinACTIVE MOIETY3H04W2810VRIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]3
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHRIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]3
cetylpyridinium chlorideINACTIVE INGREDIENTD9OM4SK49PRIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]3
D&C Red No. 33INACTIVE INGREDIENT9DBA0SBB0LRIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]3
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDRIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOARIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]3
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8RIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]3
gelatinINACTIVE INGREDIENT2G86QN327LRIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]3
lactoseINACTIVE INGREDIENTJ2B2A4N98GRIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30RIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]3
povidoneINACTIVE INGREDIENTFZ989GH94ERIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]3
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JRIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]3
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2RIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]3
starch, cornINACTIVE INGREDIENTO8232NY3SJRIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPRIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65483-093RIDAURA (AURANOFIN) CAPSULE [PROMETHEUS LABORATORIES INC.]3Legacy NDC, 1 package rows20111215_05c34ddf-a0f7-4267-83f5-d02be3defc37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197386auranofin 3 MG Oral CapsulePSN05c34ddf-a0f7-4267-83f5-d02be3defc373
213510Ridaura 3 MG Oral CapsulePSN05c34ddf-a0f7-4267-83f5-d02be3defc373
213510auranofin 3 MG Oral Capsule [Ridaura]SBD05c34ddf-a0f7-4267-83f5-d02be3defc373
197386auranofin 3 MG Oral CapsuleSCD05c34ddf-a0f7-4267-83f5-d02be3defc373
213510Ridaura 3 MG Oral CapsuleSY05c34ddf-a0f7-4267-83f5-d02be3defc373

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
65483-093-066548300930660 in 1 BOTTLEHistorical