sildenafil

Generic: sildenafil

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

Drug Facts

Product Profile

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

sildenafil citrate 25 mg/1

Manufacturer
Exelan Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 76282-643
Product ID 76282-643_2feb2e90-dc79-4542-87c5-42653c624704
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207178
Listing Expiration 2026-12-31
Marketing Start 2022-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76282643
Hyphenated Format 76282-643

Supplemental Identifiers

RxCUI
312950 314228 314229
UPC
0376282644011 0376282645308 0376282644301 0376282643304 0376282645018
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 ANDA207178 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (76282-643-30)
source: ndc

Packages (1)

76282-643-30 30 TABLET in 1 BOTTLE (76282-643-30)

Ingredients (1)

sildenafil citrate (25 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": "2feb2e90-dc79-4542-87c5-42653c624704", "openfda": {"upc": ["0376282644011", "0376282645308", "0376282644301", "0376282643304", "0376282645018"], "unii": ["BW9B0ZE037"], "rxcui": ["312950", "314228", "314229"], "spl_set_id": ["1883785c-a1a4-48fe-b722-afacf2875ca8"], "manufacturer_name": ["Exelan Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (76282-643-30)", "package_ndc": "76282-643-30", "marketing_start_date": "20220701"}], "brand_name": "SILDENAFIL", "product_id": "76282-643_2feb2e90-dc79-4542-87c5-42653c624704", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "76282-643", "generic_name": "SILDENAFIL", "labeler_name": "Exelan Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SILDENAFIL", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "25 mg/1"}], "application_number": "ANDA207178", "marketing_category": "ANDA", "marketing_start_date": "20220701", "listing_expiration_date": "20261231"}