sildenafil citrate

Generic: sildenafil citrate

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sildenafil citrate
Generic Name sildenafil citrate
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sildenafil citrate 20 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-613
Product ID 76420-613_05373fec-0f63-7fd4-e063-6394a90af72d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091479
Listing Expiration 2026-12-31
Marketing Start 2012-11-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420613
Hyphenated Format 76420-613

Supplemental Identifiers

RxCUI
577033
UNII
BW9B0ZE037

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 ANDA091479 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (76420-613-30)
  • 60 TABLET in 1 BOTTLE (76420-613-60)
  • 90 TABLET in 1 BOTTLE (76420-613-90)
source: ndc

Packages (3)

76420-613-30 30 TABLET in 1 BOTTLE (76420-613-30) 76420-613-60 60 TABLET in 1 BOTTLE (76420-613-60) 76420-613-90 90 TABLET in 1 BOTTLE (76420-613-90)

Ingredients (1)

sildenafil citrate (20 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": "05373fec-0f63-7fd4-e063-6394a90af72d", "openfda": {"unii": ["BW9B0ZE037"], "rxcui": ["577033"], "spl_set_id": ["49a95b25-08b3-4cfe-a60b-c5132c280be2"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (76420-613-30)", "package_ndc": "76420-613-30", "marketing_start_date": "20230913"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (76420-613-60)", "package_ndc": "76420-613-60", "marketing_start_date": "20230913"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (76420-613-90)", "package_ndc": "76420-613-90", "marketing_start_date": "20230913"}], "brand_name": "SILDENAFIL CITRATE", "product_id": "76420-613_05373fec-0f63-7fd4-e063-6394a90af72d", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "76420-613", "generic_name": "SILDENAFIL CITRATE", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SILDENAFIL CITRATE", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "20 mg/1"}], "application_number": "ANDA091479", "marketing_category": "ANDA", "marketing_start_date": "20121106", "listing_expiration_date": "20261231"}