sildenafil citrate

Generic: sildenafil citrate

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

Drug Facts

Product Profile

Brand Name sildenafil citrate
Generic Name sildenafil citrate
Labeler aurobindo pharma limited
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

sildenafil citrate 10 mg/mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-420
Product ID 59651-420_39509319-16be-4fc4-a60a-48ea8e9333c6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214773
Listing Expiration 2027-12-31
Marketing Start 2022-12-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651420
Hyphenated Format 59651-420

Supplemental Identifiers

RxCUI
1307427
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 ANDA214773 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (59651-420-11) / 112 mL in 1 BOTTLE
source: ndc

Packages (1)

59651-420-11 1 BOTTLE in 1 CARTON (59651-420-11) / 112 mL in 1 BOTTLE

Ingredients (1)

sildenafil citrate (10 mg/mL)

Linked Drug Pages (1)

sildenafil CITRATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "39509319-16be-4fc4-a60a-48ea8e9333c6", "openfda": {"unii": ["BW9B0ZE037"], "rxcui": ["1307427"], "spl_set_id": ["b60b4fdc-9b78-45e6-8438-8a30f83ed976"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (59651-420-11)  / 112 mL in 1 BOTTLE", "package_ndc": "59651-420-11", "marketing_start_date": "20221223"}], "brand_name": "sildenafil CITRATE", "product_id": "59651-420_39509319-16be-4fc4-a60a-48ea8e9333c6", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "59651-420", "generic_name": "sildenafil CITRATE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "sildenafil CITRATE", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "10 mg/mL"}], "application_number": "ANDA214773", "marketing_category": "ANDA", "marketing_start_date": "20221223", "listing_expiration_date": "20271231"}