sildenafil

Generic: sildenafil

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sildenafil
Generic Name sildenafil
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sildenafil citrate 100 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-043
Product ID 33342-043_e89d523d-8d42-4bbf-be3d-2b15e7c15f4f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202255
Listing Expiration 2026-12-31
Marketing Start 2023-04-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342043
Hyphenated Format 33342-043

Supplemental Identifiers

RxCUI
312950 314228 314229
UPC
0333342043443 0333342042446
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 ANDA202255 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (33342-043-07)
  • 100 TABLET, FILM COATED in 1 BOTTLE (33342-043-11)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (33342-043-44)
  • 1 BLISTER PACK in 1 CARTON (33342-043-98) / 60 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (4)

33342-043-07 30 TABLET, FILM COATED in 1 BOTTLE (33342-043-07) 33342-043-11 100 TABLET, FILM COATED in 1 BOTTLE (33342-043-11) 33342-043-44 1000 TABLET, FILM COATED in 1 BOTTLE (33342-043-44) 33342-043-98 1 BLISTER PACK in 1 CARTON (33342-043-98) / 60 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

sildenafil citrate (100 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": "e89d523d-8d42-4bbf-be3d-2b15e7c15f4f", "openfda": {"upc": ["0333342043443", "0333342042446"], "unii": ["BW9B0ZE037"], "rxcui": ["312950", "314228", "314229"], "spl_set_id": ["c2b25818-99a3-474b-a04c-929df1110834"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (33342-043-07)", "package_ndc": "33342-043-07", "marketing_start_date": "20230419"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (33342-043-11)", "package_ndc": "33342-043-11", "marketing_start_date": "20230419"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (33342-043-44)", "package_ndc": "33342-043-44", "marketing_start_date": "20230419"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (33342-043-98)  / 60 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "33342-043-98", "marketing_start_date": "20230419"}], "brand_name": "Sildenafil", "product_id": "33342-043_e89d523d-8d42-4bbf-be3d-2b15e7c15f4f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "33342-043", "generic_name": "Sildenafil", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sildenafil", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "100 mg/1"}], "application_number": "ANDA202255", "marketing_category": "ANDA", "marketing_start_date": "20230419", "listing_expiration_date": "20261231"}