sildenafil

Generic: sildenafil

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

sildenafil 10 mg/mL

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 60219-2651
Product ID 60219-2651_d13c8373-568f-485b-8b2e-94c2a2a2277e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211092
Listing Expiration 2026-12-31
Marketing Start 2024-03-02

Pharmacologic Class

Established (EPC)
phosphodiesterase 5 inhibitor [epc]
Mechanism of Action
phosphodiesterase 5 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 602192651
Hyphenated Format 60219-2651

Supplemental Identifiers

RxCUI
1307427
UNII
3M7OB98Y7H
NUI
N0000175599 N0000020026

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 ANDA211092 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (60219-2651-1) / 112 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

60219-2651-1 1 BOTTLE, GLASS in 1 CARTON (60219-2651-1) / 112 mL in 1 BOTTLE, GLASS

Ingredients (1)

sildenafil (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": "d13c8373-568f-485b-8b2e-94c2a2a2277e", "openfda": {"nui": ["N0000175599", "N0000020026"], "unii": ["3M7OB98Y7H"], "rxcui": ["1307427"], "spl_set_id": ["845e6f49-2d5d-48b1-9ce5-26351536cbff"], "pharm_class_epc": ["Phosphodiesterase 5 Inhibitor [EPC]"], "pharm_class_moa": ["Phosphodiesterase 5 Inhibitors [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (60219-2651-1)  / 112 mL in 1 BOTTLE, GLASS", "package_ndc": "60219-2651-1", "marketing_start_date": "20240302"}], "brand_name": "Sildenafil", "product_id": "60219-2651_d13c8373-568f-485b-8b2e-94c2a2a2277e", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "60219-2651", "generic_name": "Sildenafil", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sildenafil", "active_ingredients": [{"name": "SILDENAFIL", "strength": "10 mg/mL"}], "application_number": "ANDA211092", "marketing_category": "ANDA", "marketing_start_date": "20240302", "listing_expiration_date": "20261231"}