sildenafil

Generic: sildenafil

Labeler: bostal llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sildenafil
Generic Name sildenafil
Labeler bostal llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sildenafil citrate 50 mg/1

Manufacturer
Bostal LLC

Identifiers & Regulatory

Product NDC 35561-252
Product ID 35561-252_49fc9324-58cc-2875-e063-6394a90a5363
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208494
Listing Expiration 2027-12-31
Marketing Start 2020-04-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 35561252
Hyphenated Format 35561-252

Supplemental Identifiers

RxCUI
312950 314228 314229
UPC
0335561253146 0335561252149 0335561251142
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 ANDA208494 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (35561-252-10)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (35561-252-14)
source: ndc

Packages (2)

35561-252-10 30 TABLET, FILM COATED in 1 BOTTLE (35561-252-10) 35561-252-14 1000 TABLET, FILM COATED in 1 BOTTLE (35561-252-14)

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": "49fc9324-58cc-2875-e063-6394a90a5363", "openfda": {"upc": ["0335561253146", "0335561252149", "0335561251142"], "unii": ["BW9B0ZE037"], "rxcui": ["312950", "314228", "314229"], "spl_set_id": ["428bbcff-0faf-499c-81b2-6ac76c0687c0"], "manufacturer_name": ["Bostal LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (35561-252-10)", "package_ndc": "35561-252-10", "marketing_start_date": "20200422"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (35561-252-14)", "package_ndc": "35561-252-14", "marketing_start_date": "20200422"}], "brand_name": "Sildenafil", "product_id": "35561-252_49fc9324-58cc-2875-e063-6394a90a5363", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "35561-252", "generic_name": "sildenafil", "labeler_name": "Bostal LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sildenafil", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "50 mg/1"}], "application_number": "ANDA208494", "marketing_category": "ANDA", "marketing_start_date": "20200422", "listing_expiration_date": "20271231"}