sildenafil citrate

Generic: sildenafil

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

Drug Facts

Product Profile

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

sildenafil citrate 100 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-188
Product ID 13668-188_e835d1de-642e-4ea7-98ff-390effd8331f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091448
Listing Expiration 2027-12-31
Marketing Start 2018-06-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13668188
Hyphenated Format 13668-188

Supplemental Identifiers

RxCUI
312950 314228 314229
UPC
0313668187304 0313668186307
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 (source: ndc)
Application Number ANDA091448 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (13668-188-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (13668-188-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (13668-188-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (13668-188-30)
source: ndc

Packages (4)

13668-188-01 100 TABLET, FILM COATED in 1 BOTTLE (13668-188-01) 13668-188-05 500 TABLET, FILM COATED in 1 BOTTLE (13668-188-05) 13668-188-10 1000 TABLET, FILM COATED in 1 BOTTLE (13668-188-10) 13668-188-30 30 TABLET, FILM COATED in 1 BOTTLE (13668-188-30)

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": "e835d1de-642e-4ea7-98ff-390effd8331f", "openfda": {"upc": ["0313668187304", "0313668186307"], "unii": ["BW9B0ZE037"], "rxcui": ["312950", "314228", "314229"], "spl_set_id": ["b48630b1-5208-4d00-b56f-21701f223758"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (13668-188-01)", "package_ndc": "13668-188-01", "marketing_start_date": "20180611"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (13668-188-05)", "package_ndc": "13668-188-05", "marketing_start_date": "20180611"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (13668-188-10)", "package_ndc": "13668-188-10", "marketing_start_date": "20180611"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (13668-188-30)", "package_ndc": "13668-188-30", "marketing_start_date": "20180611"}], "brand_name": "SILDENAFIL CITRATE", "product_id": "13668-188_e835d1de-642e-4ea7-98ff-390effd8331f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "13668-188", "generic_name": "SILDENAFIL", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SILDENAFIL CITRATE", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "100 mg/1"}], "application_number": "ANDA091448", "marketing_category": "ANDA", "marketing_start_date": "20180611", "listing_expiration_date": "20271231"}