FDA.reportPublic FDA data

RAPAFLO

Product NDC
52544-152
11-digit product format
525440152
Labeler code
52544
Product ID
52544-152_01d2cfa3-9fd9-44ef-91db-71e5800d838d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
silodosin
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
NDA022206
Marketing category
NDA
Marketing start
2009-03-23
Marketing end
2020-02-29
Substance
SILODOSIN
Active strength
8 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52544-152-19EA - Each52544-152e42c09b4-6daf-4274-988d-6b0f653869c912012-07-24
52544-152-30EA - Each52544-1521f3dcad0-0bfa-4e46-a5c2-0bd8102fe3a412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SILODOSINACTIVE INGREDIENTCUZ39LUY82RAPAFLO (SILODOSIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
SILODOSINACTIVE MOIETYCUZ39LUY82RAPAFLO (SILODOSIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809481Rapaflo 8 MG Oral CapsulePSN96425d91-cfe1-477d-a130-b58c330ca8a33
809477silodosin 8 MG Oral CapsulePSN96425d91-cfe1-477d-a130-b58c330ca8a33
809481silodosin 8 MG Oral Capsule [Rapaflo]SBD96425d91-cfe1-477d-a130-b58c330ca8a33
809477silodosin 8 MG Oral CapsuleSCD96425d91-cfe1-477d-a130-b58c330ca8a33
809481Rapaflo 8 MG Oral CapsuleSY96425d91-cfe1-477d-a130-b58c330ca8a33