FDA.reportPublic FDA data

Sildenafil

Manufacturer
Altergon Italia srl | IBSA Institut Biochimique SA
Effective date
2026-02-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:34:05

Label at a glance#

ProductSildenafil
Active ingredientSILDENAFIL CITRATE
Label structure9 sections

Label contents#

Full prescribing information#

1.INDICATIONSAND USAGE

INDICATIONS & USAGE SECTION

SILDENAFIL ORAL FILM is indicated for the treatment of erectile dysfunction.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 43328-020-04
25 mg
Sildenafil oral film
25 mg per oral film

25 pack 425 pack 4

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 43328-020-08
25 mg
Sildenafil oral film
25 mg per oral film

25 pack 825 pack 8

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 43328-021-04
50 mg
Sildenafil oral film
50 mg per oral film

50 pack 450 pack 4

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 43328-021-08
75 mg
Sildenafil oral film
75 mg per oral film

50 pack 850 pack 8

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 43328-022-04
75 mg
Sildenafil oral film
75 mg per oral film

75 pack 475 pack 4

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 43328-020-08
75 mg
Sildenafil oral film
75 mg per oral film

75 pack 875 pack 8

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 43328-023-04
100 mg
Sildenafil oral film
100 mg per oral film

100 pack 4100 pack 4

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 43328-023-08
100 mg
Sildenafil oral film
100 mg per oral film

100 pack 8100 pack 8

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43328-02043328-020-01, 43328-020-04, 43328-020-08
43328-02143328-021-01, 43328-021-04, 43328-021-08
43328-02243328-022-01, 43328-022-04, 43328-022-08
43328-02343328-023-01, 43328-023-04, 43328-023-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
MALTODEXTRIN7CVR7L4A2DIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL MONOCAPRYLATERT9P9S09QIIACT
SUCRALOSE96K6UQ3ZD4IACT
POLYSORBATE 207T1F30V5YHIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
SILDENAFIL CITRATEBW9B0ZE037ACTIM
MALTODEXTRIN7CVR7L4A2DIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL MONOCAPRYLATERT9P9S09QIIACT
SUCRALOSE96K6UQ3ZD4IACT
POLYSORBATE 207T1F30V5YHIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
SILDENAFIL CITRATEBW9B0ZE037ACTIM
MALTODEXTRIN7CVR7L4A2DIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL MONOCAPRYLATERT9P9S09QIIACT
SUCRALOSE96K6UQ3ZD4IACT
POLYSORBATE 207T1F30V5YHIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
SILDENAFIL CITRATEBW9B0ZE037ACTIM
MALTODEXTRIN7CVR7L4A2DIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL MONOCAPRYLATERT9P9S09QIIACT
SUCRALOSE96K6UQ3ZD4IACT
POLYSORBATE 207T1F30V5YHIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
SILDENAFIL CITRATEBW9B0ZE037ACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
49eb78c3-9796-6708-e063-6294a90ad6e549eb7ff2-142a-43e0-e063-6394a90a20542026-02-03Exact identifier
spl id: 49eb78c3-9796-6708-e063-6294a90ad6e5
spl set id: 49eb7ff2-142a-43e0-e063-6394a90a2054

Reported adverse events (FAERS/openFDA)#

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