sildenafil

Generic: sildenafil

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sildenafil
Generic Name sildenafil
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sildenafil citrate 100 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-691
Product ID 65862-691_98bf3100-9a4e-45d5-9f6b-1fa1a06b26b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203962
Listing Expiration 2026-12-31
Marketing Start 2018-06-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862691
Hyphenated Format 65862-691

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 (source: ndc)
Generic Name sildenafil (source: ndc)
Application Number ANDA203962 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-691-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-691-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-691-30)
source: ndc

Packages (3)

65862-691-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-691-01) 65862-691-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-691-05) 65862-691-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-691-30)

Ingredients (1)

sildenafil citrate (100 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": "98bf3100-9a4e-45d5-9f6b-1fa1a06b26b8", "openfda": {"unii": ["BW9B0ZE037"], "rxcui": ["312950", "314228", "314229"], "spl_set_id": ["363c1e77-e482-47b2-aa1e-851abd770aeb"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-691-01)", "package_ndc": "65862-691-01", "marketing_start_date": "20180611"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-691-05)", "package_ndc": "65862-691-05", "marketing_start_date": "20180611"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-691-30)", "package_ndc": "65862-691-30", "marketing_start_date": "20180611"}], "brand_name": "Sildenafil", "product_id": "65862-691_98bf3100-9a4e-45d5-9f6b-1fa1a06b26b8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "65862-691", "generic_name": "Sildenafil", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sildenafil", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "100 mg/1"}], "application_number": "ANDA203962", "marketing_category": "ANDA", "marketing_start_date": "20180611", "listing_expiration_date": "20261231"}