sildenafil citrate

Generic: sildenafil

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

Drug Facts

Product Profile

Brand Name sildenafil citrate
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 68071-3646
Product ID 68071-3646_2a2fe9ea-d9e4-9057-e063-6394a90af294
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206401
Listing Expiration 2026-12-31
Marketing Start 2024-07-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713646
Hyphenated Format 68071-3646

Supplemental Identifiers

RxCUI
312950
UPC
0368071364613
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 (source: ndc)
Application Number ANDA206401 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE (68071-3646-1)
source: ndc

Packages (1)

68071-3646-1 10 TABLET, FILM COATED in 1 BOTTLE (68071-3646-1)

Ingredients (1)

sildenafil citrate (50 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": "2a2fe9ea-d9e4-9057-e063-6394a90af294", "openfda": {"upc": ["0368071364613"], "unii": ["BW9B0ZE037"], "rxcui": ["312950"], "spl_set_id": ["1d614710-708e-f11c-e063-6394a90a05a5"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (68071-3646-1)", "package_ndc": "68071-3646-1", "marketing_start_date": "20240716"}], "brand_name": "Sildenafil Citrate", "product_id": "68071-3646_2a2fe9ea-d9e4-9057-e063-6394a90af294", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "68071-3646", "generic_name": "Sildenafil", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sildenafil Citrate", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "50 mg/1"}], "application_number": "ANDA206401", "marketing_category": "ANDA", "marketing_start_date": "20240716", "listing_expiration_date": "20261231"}