FDA.reportPublic FDA data

Silodosin

Product NDC
68180-741
11-digit product format
681800741
Labeler code
68180
Product ID
68180-741_9a808ee1-339e-42a3-b55c-b655c9d1fcb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Silodosin
Dosage form
CAPSULE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA206541
Marketing category
ANDA
Marketing start
2018-12-03
Substance
SILODOSIN
Active strength
8 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILODOSIN8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCUZ39LUY82
Rxcui809477, 826612

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
089fe5d1-1a90-7a8e-a24a-107c84472400Product name420200507
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-741-02Silodosin500 in 1 BOTTLECAPSULE50011
68180-741-06Silodosin30 in 1 BOTTLECAPSULE3011
68180-741-09Silodosin90 in 1 BOTTLECAPSULE9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-741-06EA - Each68180-741e54b70e6-0df9-4980-891c-ea79487aaade12019-01-24
68180-741-09EA - Each68180-7416697695d-19a8-4a00-bfa7-b0823fa7921c12019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-741SILODOSIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 3 package rows20250206_2300db48-477f-4357-8de9-f723737071b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
826612silodosin 4 MG Oral CapsulePSN2300db48-477f-4357-8de9-f723737071b411
809477silodosin 8 MG Oral CapsulePSN2300db48-477f-4357-8de9-f723737071b411
826612silodosin 4 MG Oral CapsuleSCD2300db48-477f-4357-8de9-f723737071b411
809477silodosin 8 MG Oral CapsuleSCD2300db48-477f-4357-8de9-f723737071b411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-741-0268180074102500 CAPSULE in 1 BOTTLE (68180-741-02) 500 capsule2018-12-030000-00-00NoNoCurrent
68180-741-066818007410630 CAPSULE in 1 BOTTLE (68180-741-06) 30 capsule2018-12-030000-00-00NoNoCurrent
68180-741-096818007410990 CAPSULE in 1 BOTTLE (68180-741-09) 90 capsule2018-12-030000-00-00NoNoCurrent