sildenafil

Generic: sildenafil

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sildenafil
Generic Name sildenafil
Labeler amneal pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sildenafil citrate 20 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-351
Product ID 65162-351_fcdd909b-5c4f-4055-8a2a-61c672d68994
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202025
Listing Expiration 2026-12-31
Marketing Start 2012-11-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162351
Hyphenated Format 65162-351

Supplemental Identifiers

RxCUI
577033
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 (source: ndc)
Generic Name sildenafil (source: ndc)
Application Number ANDA202025 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (65162-351-09)
  • 1000 TABLET in 1 BOTTLE (65162-351-11)
source: ndc

Packages (2)

65162-351-09 90 TABLET in 1 BOTTLE (65162-351-09) 65162-351-11 1000 TABLET in 1 BOTTLE (65162-351-11)

Ingredients (1)

sildenafil citrate (20 mg/1)

Linked Drug Pages (1)

Sildenafil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fcdd909b-5c4f-4055-8a2a-61c672d68994", "openfda": {"unii": ["BW9B0ZE037"], "rxcui": ["577033"], "spl_set_id": ["187de471-3e79-44ed-b560-0f8b2d549f74"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (65162-351-09)", "package_ndc": "65162-351-09", "marketing_start_date": "20121108"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65162-351-11)", "package_ndc": "65162-351-11", "marketing_start_date": "20121108"}], "brand_name": "Sildenafil", "product_id": "65162-351_fcdd909b-5c4f-4055-8a2a-61c672d68994", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "65162-351", "generic_name": "Sildenafil", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sildenafil", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "20 mg/1"}], "application_number": "ANDA202025", "marketing_category": "ANDA", "marketing_start_date": "20121108", "listing_expiration_date": "20261231"}