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 20 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-688
Product ID 65862-688_aee36818-4865-49b7-9f54-29c62f8d4fda
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203963
Listing Expiration 2027-12-31
Marketing Start 2015-11-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862688
Hyphenated Format 65862-688

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 ANDA203963 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (65862-688-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-688-99)
source: ndc

Packages (2)

65862-688-90 90 TABLET, FILM COATED in 1 BOTTLE (65862-688-90) 65862-688-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-688-99)

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": "aee36818-4865-49b7-9f54-29c62f8d4fda", "openfda": {"unii": ["BW9B0ZE037"], "rxcui": ["577033"], "spl_set_id": ["17621e92-79a0-46aa-86c7-ea179e81928d"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65862-688-90)", "package_ndc": "65862-688-90", "marketing_start_date": "20151118"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-688-99)", "package_ndc": "65862-688-99", "marketing_start_date": "20151118"}], "brand_name": "Sildenafil", "product_id": "65862-688_aee36818-4865-49b7-9f54-29c62f8d4fda", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "65862-688", "generic_name": "Sildenafil", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sildenafil", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "20 mg/1"}], "application_number": "ANDA203963", "marketing_category": "ANDA", "marketing_start_date": "20151118", "listing_expiration_date": "20271231"}