sildenafil citrate

Generic: sildenafil citrate

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

Drug Facts

Product Profile

Brand Name sildenafil citrate
Generic Name sildenafil citrate
Labeler nivagen pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sildenafil citrate 100 mg/1

Manufacturer
NIVAGEN PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 75834-241
Product ID 75834-241_458101cb-836f-7660-e063-6294a90ac3e8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209302
Listing Expiration 2026-12-31
Marketing Start 2020-09-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75834241
Hyphenated Format 75834-241

Supplemental Identifiers

RxCUI
312950 314228 314229
UPC
0375834272900 0375834241012 0375834241302 0375834240015 0375834272009 0375834240008 0375834272306 0375834240305 0375834241005 0375834240053
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 citrate (source: ndc)
Generic Name sildenafil citrate (source: ndc)
Application Number ANDA209302 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (75834-241-00)
  • 100 TABLET in 1 BOTTLE (75834-241-01)
  • 500 TABLET in 1 BOTTLE (75834-241-05)
  • 30 TABLET in 1 BOTTLE (75834-241-30)
source: ndc

Packages (4)

75834-241-00 1000 TABLET in 1 BOTTLE (75834-241-00) 75834-241-01 100 TABLET in 1 BOTTLE (75834-241-01) 75834-241-05 500 TABLET in 1 BOTTLE (75834-241-05) 75834-241-30 30 TABLET in 1 BOTTLE (75834-241-30)

Ingredients (1)

sildenafil citrate (100 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": "458101cb-836f-7660-e063-6294a90ac3e8", "openfda": {"upc": ["0375834272900", "0375834241012", "0375834241302", "0375834240015", "0375834272009", "0375834240008", "0375834272306", "0375834240305", "0375834241005", "0375834240053"], "unii": ["BW9B0ZE037"], "rxcui": ["312950", "314228", "314229"], "spl_set_id": ["5ac95dd0-57e4-495c-bf8d-b2e5bbe33e20"], "manufacturer_name": ["NIVAGEN PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (75834-241-00)", "package_ndc": "75834-241-00", "marketing_start_date": "20200904"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (75834-241-01)", "package_ndc": "75834-241-01", "marketing_start_date": "20200904"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (75834-241-05)", "package_ndc": "75834-241-05", "marketing_start_date": "20200904"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (75834-241-30)", "package_ndc": "75834-241-30", "marketing_start_date": "20200904"}], "brand_name": "SILDENAFIL CITRATE", "product_id": "75834-241_458101cb-836f-7660-e063-6294a90ac3e8", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "75834-241", "generic_name": "SILDENAFIL CITRATE", "labeler_name": "NIVAGEN PHARMACEUTICALS, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SILDENAFIL CITRATE", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "100 mg/1"}], "application_number": "ANDA209302", "marketing_category": "ANDA", "marketing_start_date": "20200904", "listing_expiration_date": "20261231"}