sildenafil

Generic: sildenafil

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

Drug Facts

Product Profile

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

sildenafil citrate 100 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-5343
Product ID 0093-5343_f85e5bfc-be48-4675-8867-1585f412ccb6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077342
Listing Expiration 2026-12-31
Marketing Start 2017-12-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00935343
Hyphenated Format 0093-5343

Supplemental Identifiers

RxCUI
312950 314228 314229
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 ANDA077342 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (0093-5343-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (0093-5343-56)
source: ndc

Packages (2)

0093-5343-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-5343-01) 0093-5343-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-5343-56)

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": "f85e5bfc-be48-4675-8867-1585f412ccb6", "openfda": {"unii": ["BW9B0ZE037"], "rxcui": ["312950", "314228", "314229"], "spl_set_id": ["5cbac450-f336-45bd-8d10-9ecfd21866eb"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0093-5343-01)", "package_ndc": "0093-5343-01", "marketing_start_date": "20171211"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0093-5343-56)", "package_ndc": "0093-5343-56", "marketing_start_date": "20171211"}], "brand_name": "Sildenafil", "product_id": "0093-5343_f85e5bfc-be48-4675-8867-1585f412ccb6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "0093-5343", "generic_name": "Sildenafil", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sildenafil", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "100 mg/1"}], "application_number": "ANDA077342", "marketing_category": "ANDA", "marketing_start_date": "20171211", "listing_expiration_date": "20261231"}