Silodosin

Product NDC
42291-777
11-digit product format
422910777
Labeler code
42291
Product ID
42291-777_4875ae6d-fc8a-e013-e063-6394a90a97f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Silodosin
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA209745
Marketing category
ANDA
Marketing start
2022-10-04
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
42291-777-30Silodosin30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-777-30EA - Each42291-77790bcac83-bdd6-455f-bdab-8470257cee0312022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-777SILODOSIN CAPSULE [AVKARE]2Current NDC, Legacy NDC, 1 package rows20240111_ea3bbafb-d32a-d0d3-e053-2a95a90ac387.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
826612silodosin 4 MG Oral CapsulePSNea3bbafb-d32a-d0d3-e053-2a95a90ac3873
809477silodosin 8 MG Oral CapsulePSNea3bbafb-d32a-d0d3-e053-2a95a90ac3873
826612silodosin 4 MG Oral CapsuleSCDea3bbafb-d32a-d0d3-e053-2a95a90ac3873
809477silodosin 8 MG Oral CapsuleSCDea3bbafb-d32a-d0d3-e053-2a95a90ac3873

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-777-304229107773030 CAPSULE in 1 BOTTLE (42291-777-30) 30 capsule2022-10-040000-00-00NoNoCurrent