Silodosin

Product NDC
69238-1421
11-digit product format
692381421
Labeler code
69238
Product ID
69238-1421_36fb79b1-8d84-4afa-b26c-78a83394140d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Silodosin
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA209745
Marketing category
ANDA
Marketing start
2018-12-03
Substance
SILODOSIN
Active strength
4 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Silodosin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILODOSIN4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCUZ39LUY82
Rxcui809477, 826612

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
089fe5d1-1a90-7a8e-a24a-107c84472400Product name420200507

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1421-3Silodosin30 in 1 BOTTLECAPSULE308
69238-1421-9Silodosin90 in 1 BOTTLECAPSULE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1421-3EA - Each69238-14213ab87f35-9a96-47f7-819a-5b1ec2f61e3712019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1421SILODOSIN CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]7Current NDC, Legacy NDC, 2 package rows20231231_de619e27-9384-4b86-abdc-de0557cd39e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
826612silodosin 4 MG Oral CapsulePSNde619e27-9384-4b86-abdc-de0557cd39e88
809477silodosin 8 MG Oral CapsulePSNde619e27-9384-4b86-abdc-de0557cd39e88
826612silodosin 4 MG Oral CapsuleSCDde619e27-9384-4b86-abdc-de0557cd39e88
809477silodosin 8 MG Oral CapsuleSCDde619e27-9384-4b86-abdc-de0557cd39e88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1421-36923814210330 CAPSULE in 1 BOTTLE (69238-1421-3) 30 capsule2018-12-030000-00-00NoNoCurrent
69238-1421-96923814210990 CAPSULE in 1 BOTTLE (69238-1421-9) 90 capsule2018-12-030000-00-00NoNoCurrent