sildenafil

Generic: sildenafil

Labeler: reyoung corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sildenafil
Generic Name sildenafil
Labeler reyoung corporation
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sildenafil citrate 100 mg/1

Manufacturer
Reyoung Corporation

Identifiers & Regulatory

Product NDC 82647-212
Product ID 82647-212_49fd0cc5-980e-c7d1-e063-6394a90a85c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208494
Listing Expiration 2027-12-31
Marketing Start 2022-03-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82647212
Hyphenated Format 82647-212

Supplemental Identifiers

RxCUI
312950 314228 314229
UPC
0382647211149 0382647210142
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
  • 100 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (82647-212-14)
  • 30 TABLET, FILM COATED in 1 BOTTLE (82647-212-30)
source: ndc

Packages (2)

82647-212-14 1000 TABLET, FILM COATED in 1 BOTTLE (82647-212-14) 82647-212-30 30 TABLET, FILM COATED in 1 BOTTLE (82647-212-30)

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": "49fd0cc5-980e-c7d1-e063-6394a90a85c0", "openfda": {"upc": ["0382647211149", "0382647210142"], "unii": ["BW9B0ZE037"], "rxcui": ["312950", "314228", "314229"], "spl_set_id": ["dc998a9c-0770-111b-e053-2a95a90a88a4"], "manufacturer_name": ["Reyoung Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (82647-212-14)", "package_ndc": "82647-212-14", "marketing_start_date": "20220328"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (82647-212-30)", "package_ndc": "82647-212-30", "marketing_start_date": "20220328"}], "brand_name": "Sildenafil", "product_id": "82647-212_49fd0cc5-980e-c7d1-e063-6394a90a85c0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "82647-212", "generic_name": "sildenafil", "labeler_name": "Reyoung Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sildenafil", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "100 mg/1"}], "application_number": "ANDA208494", "marketing_category": "ANDA", "marketing_start_date": "20220328", "listing_expiration_date": "20271231"}