sildenafil

Generic: sildenafil

Labeler: virtus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sildenafil
Generic Name sildenafil
Labeler virtus pharmaceuticals, llc
Dosage Form FOR SUSPENSION
Routes
ORAL
Active Ingredients

sildenafil citrate 10 mg/mL

Manufacturer
Virtus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69543-419
Product ID 69543-419_02b1c256-2d9e-4dc2-a034-ea50d1699bf9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213814
Listing Expiration 2026-12-31
Marketing Start 2021-08-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69543419
Hyphenated Format 69543-419

Supplemental Identifiers

RxCUI
1307427
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 ANDA213814 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (69543-419-72) / 112 mL in 1 BOTTLE
source: ndc

Packages (1)

69543-419-72 1 BOTTLE in 1 CARTON (69543-419-72) / 112 mL in 1 BOTTLE

Ingredients (1)

sildenafil citrate (10 mg/mL)

Linked Drug Pages (1)

sildenafil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "02b1c256-2d9e-4dc2-a034-ea50d1699bf9", "openfda": {"unii": ["BW9B0ZE037"], "rxcui": ["1307427"], "spl_set_id": ["8526e8f2-4bb4-430b-9e38-68ee68caa5a4"], "manufacturer_name": ["Virtus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69543-419-72)  / 112 mL in 1 BOTTLE", "package_ndc": "69543-419-72", "marketing_start_date": "20210802"}], "brand_name": "sildenafil", "product_id": "69543-419_02b1c256-2d9e-4dc2-a034-ea50d1699bf9", "dosage_form": "FOR SUSPENSION", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "69543-419", "generic_name": "sildenafil", "labeler_name": "Virtus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "sildenafil", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "10 mg/mL"}], "application_number": "ANDA213814", "marketing_category": "ANDA", "marketing_start_date": "20210802", "listing_expiration_date": "20261231"}