sildenafil

Generic: sildenafil

Labeler: nucare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sildenafil
Generic Name sildenafil
Labeler nucare pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sildenafil citrate 50 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3745
Product ID 68071-3745_45c93036-57c7-efb3-e063-6294a90a1965
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 680713745
Hyphenated Format 68071-3745

Supplemental Identifiers

RxCUI
312950
UPC
0368071374568
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 (source: ndc)
Generic Name sildenafil (source: ndc)
Application Number ANDA203962 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE (68071-3745-1)
  • 45 TABLET, FILM COATED in 1 BOTTLE (68071-3745-5)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68071-3745-6)
source: ndc

Packages (3)

68071-3745-1 10 TABLET, FILM COATED in 1 BOTTLE (68071-3745-1) 68071-3745-5 45 TABLET, FILM COATED in 1 BOTTLE (68071-3745-5) 68071-3745-6 60 TABLET, FILM COATED in 1 BOTTLE (68071-3745-6)

Ingredients (1)

sildenafil citrate (50 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": "45c93036-57c7-efb3-e063-6294a90a1965", "openfda": {"upc": ["0368071374568"], "unii": ["BW9B0ZE037"], "rxcui": ["312950"], "spl_set_id": ["2916e6c4-bc68-c4d6-e063-6394a90aba79"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (68071-3745-1)", "package_ndc": "68071-3745-1", "marketing_start_date": "20251212"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (68071-3745-5)", "package_ndc": "68071-3745-5", "marketing_start_date": "20251009"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68071-3745-6)", "package_ndc": "68071-3745-6", "marketing_start_date": "20241212"}], "brand_name": "Sildenafil", "product_id": "68071-3745_45c93036-57c7-efb3-e063-6294a90a1965", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "68071-3745", "generic_name": "Sildenafil", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sildenafil", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "50 mg/1"}], "application_number": "ANDA203962", "marketing_category": "ANDA", "marketing_start_date": "20180611", "listing_expiration_date": "20261231"}