Auranofin

Product NDC
85437-093
11-digit product format
854370093
Labeler code
85437
Product ID
85437-093_42776e01-ac39-5aa4-e063-6294a90a99e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
auranofin
Dosage form
CAPSULE
Route
ORAL
Labeler
Coral Way Pharma, LLC
Application
NDA018689
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-10-29
Substance
AURANOFIN
Active strength
3 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Auranofin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AURANOFIN3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3H04W2810V
Rxcui197386

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee8d39e4-f907-4d8f-130c-6fceb48ba86aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85437-093-06Auranofin60 in 1 BOTTLECAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85437-093-06EA - Each85437-09320291e57-85a5-49a1-966b-d0a04e633eb912025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197386auranofin 3 MG Oral CapsulePSNd688978b-8b91-4377-9f1d-89b805f5747c2
197386auranofin 3 MG Oral CapsuleSCDd688978b-8b91-4377-9f1d-89b805f5747c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85437-093-068543700930660 CAPSULE in 1 BOTTLE (85437-093-06) 60 capsule2025-10-29NoNoHistorical