sildenafil

Generic: sildenafil

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sildenafil
Generic Name sildenafil
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sildenafil citrate 100 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-675
Product ID 71610-675_f4dbdb1b-c31d-4418-abd9-883eef04d5bd
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 71610675
Hyphenated Format 71610-675

Supplemental Identifiers

RxCUI
312950 314229
UNII
BW9B0ZE037

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
  • 100 mg/1
source: ndc
Packaging
  • 2 TABLET in 1 BOTTLE (71610-675-02)
  • 9 TABLET in 1 BOTTLE (71610-675-03)
  • 4 TABLET in 1 BOTTLE (71610-675-04)
  • 6 TABLET in 1 BOTTLE (71610-675-06)
  • 12 TABLET in 1 BOTTLE (71610-675-12)
  • 3 TABLET in 1 BOTTLE (71610-675-33)
  • 18 TABLET in 1 BOTTLE (71610-675-52)
source: ndc

Packages (7)

71610-675-02 2 TABLET in 1 BOTTLE (71610-675-02) 71610-675-03 9 TABLET in 1 BOTTLE (71610-675-03) 71610-675-04 4 TABLET in 1 BOTTLE (71610-675-04) 71610-675-06 6 TABLET in 1 BOTTLE (71610-675-06) 71610-675-12 12 TABLET in 1 BOTTLE (71610-675-12) 71610-675-33 3 TABLET in 1 BOTTLE (71610-675-33) 71610-675-52 18 TABLET in 1 BOTTLE (71610-675-52)

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": "f4dbdb1b-c31d-4418-abd9-883eef04d5bd", "openfda": {"unii": ["BW9B0ZE037"], "rxcui": ["312950", "314229"], "spl_set_id": ["cdab7ef5-39cb-45cc-b2bf-5f634f2f5499"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "2 TABLET in 1 BOTTLE (71610-675-02)", "package_ndc": "71610-675-02", "marketing_start_date": "20221107"}, {"sample": false, "description": "9 TABLET in 1 BOTTLE (71610-675-03)", "package_ndc": "71610-675-03", "marketing_start_date": "20221107"}, {"sample": false, "description": "4 TABLET in 1 BOTTLE (71610-675-04)", "package_ndc": "71610-675-04", "marketing_start_date": "20221107"}, {"sample": false, "description": "6 TABLET in 1 BOTTLE (71610-675-06)", "package_ndc": "71610-675-06", "marketing_start_date": "20221107"}, {"sample": false, "description": "12 TABLET in 1 BOTTLE (71610-675-12)", "package_ndc": "71610-675-12", "marketing_start_date": "20221107"}, {"sample": false, "description": "3 TABLET in 1 BOTTLE (71610-675-33)", "package_ndc": "71610-675-33", "marketing_start_date": "20221201"}, {"sample": false, "description": "18 TABLET in 1 BOTTLE (71610-675-52)", "package_ndc": "71610-675-52", "marketing_start_date": "20221107"}], "brand_name": "SILDENAFIL", "product_id": "71610-675_f4dbdb1b-c31d-4418-abd9-883eef04d5bd", "dosage_form": "TABLET", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "71610-675", "generic_name": "SILDENAFIL", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SILDENAFIL", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "100 mg/1"}], "application_number": "ANDA207178", "marketing_category": "ANDA", "marketing_start_date": "20220701", "listing_expiration_date": "20261231"}