FDA.reportPublic FDA data

Vardenafil HCl Trihydrate

Manufacturer
B&B Pharmaceuticals, Inc.
Effective date
2020-04-22
Label type
BULK INGREDIENT
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:34:31

Label at a glance#

ProductVardenafil HCl Trihydrate
Active ingredientVARDENAFIL HYDROCHLORIDE TRIHYDRATE
Label structure1 sections

Label contents#

Full prescribing information#

Vardenafil HCl Trihydrate representative sample

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vardenafil HCl Trihydrate 1000gVardenafil HCl Trihydrate 1000g

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63275-9868-4GM - Gram63275-9868e4d5c4d1-8e3e-4ea3-8c91-431edeaae5d612020-05-08
63275-9868-5GM - Gram63275-986844709f03-34db-4a7b-8525-06c4b450c06712020-05-08
63275-9868-8GM - Gram63275-9868b2b7eb5e-34bd-41e2-ac3f-ecd01f3f1e7312020-05-08
63275-9868-9GM - Gram63275-9868e7b6a199-429f-40d0-957c-0a2d0a8a14d512020-05-08

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63275-986863275-9868-4, 63275-9868-5, 63275-9868-8, 63275-9868-9

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
VARDENAFIL HYDROCHLORIDE TRIHYDRATE5M8S2CU0TSACTIB

Source Document#

Source XML · Source PDF

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.