RIDAURA

Product NDC
54766-093
11-digit product format
547660093
Labeler code
54766
Product ID
54766-093_431445cb-3625-82d8-e063-6394a90aeaea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
auranofin
Dosage form
CAPSULE
Route
ORAL
Labeler
Sebela Pharmaceuticals Inc.
Application
NDA018689
Marketing category
NDA
Marketing start
2016-12-15
Marketing end
2027-10-31
Substance
AURANOFIN
Active strength
3 mg/1
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RIDAURA

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AURANOFIN3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3H04W2810V
Rxcui197386, 213510

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54766-093-06RIDAURA60 in 1 BOTTLECAPSULE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54766-093-06EA - Each54766-093dc5f736a-c104-4a94-9a8c-9cb84ba3844e12017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54766-093RIDAURA (AURANOFIN) CAPSULE [SEBELA PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 1 package rows20181215_43ba3de1-ab2e-06f6-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197386auranofin 3 MG Oral CapsulePSN43ba3de1-ab2e-06f6-e054-00144ff8d46c5
213510Ridaura 3 MG Oral CapsulePSN43ba3de1-ab2e-06f6-e054-00144ff8d46c5
213510auranofin 3 MG Oral Capsule [Ridaura]SBD43ba3de1-ab2e-06f6-e054-00144ff8d46c5
197386auranofin 3 MG Oral CapsuleSCD43ba3de1-ab2e-06f6-e054-00144ff8d46c5
213510Ridaura 3 MG Oral CapsuleSY43ba3de1-ab2e-06f6-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54766-093-065476600930660 CAPSULE in 1 BOTTLE (54766-093-06) 60 capsule2016-12-152027-10-31NoNoCurrent