sildenafil citrate

Generic: sildenafil citrate

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name sildenafil citrate
Generic Name sildenafil citrate
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sildenafil citrate 50 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59762-0035
Product ID 59762-0035_6b8ead94-5df8-4fbd-a75e-388f8147fe5d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020895
Listing Expiration 2026-12-31
Marketing Start 2017-12-01

Pharmacologic Class

Classes
phosphodiesterase 5 inhibitor [epc] phosphodiesterase 5 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 597620035
Hyphenated Format 59762-0035

Supplemental Identifiers

RxCUI
312950 314228 314229
UNII
BW9B0ZE037

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sildenafil citrate (source: ndc)
Generic Name sildenafil citrate (source: ndc)
Application Number NDA020895 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (59762-0035-1)
  • 100 TABLET, FILM COATED in 1 BOTTLE (59762-0035-2)
source: ndc

Packages (2)

59762-0035-1 30 TABLET, FILM COATED in 1 BOTTLE (59762-0035-1) 59762-0035-2 100 TABLET, FILM COATED in 1 BOTTLE (59762-0035-2)

Ingredients (1)

sildenafil citrate (50 mg/1)

Linked Drug Pages (1)

Sildenafil Citrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6b8ead94-5df8-4fbd-a75e-388f8147fe5d", "openfda": {"unii": ["BW9B0ZE037"], "rxcui": ["312950", "314228", "314229"], "spl_set_id": ["98a9897b-0cbc-4ea6-9ac2-4dd719a2ede0"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (59762-0035-1)", "package_ndc": "59762-0035-1", "marketing_end_date": "20261031", "marketing_start_date": "20171201"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (59762-0035-2)", "package_ndc": "59762-0035-2", "marketing_start_date": "20171201"}], "brand_name": "Sildenafil Citrate", "product_id": "59762-0035_6b8ead94-5df8-4fbd-a75e-388f8147fe5d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "59762-0035", "generic_name": "sildenafil citrate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sildenafil Citrate", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "50 mg/1"}], "application_number": "NDA020895", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20171201", "listing_expiration_date": "20261231"}