sildenafil citrate

Generic: sildenafil citrate

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sildenafil citrate
Generic Name sildenafil citrate
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

sildenafil citrate 10 mg/mL

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 70710-1716
Product ID 70710-1716_b42790ec-b9ad-4b34-b98d-dfb8d246eff2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215708
Listing Expiration 2027-12-31
Marketing Start 2022-10-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707101716
Hyphenated Format 70710-1716

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 citrate (source: ndc)
Generic Name sildenafil citrate (source: ndc)
Application Number ANDA215708 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (70710-1716-4) / 112 mL in 1 BOTTLE, GLASS
  • 1 BOTTLE, PLASTIC in 1 CARTON (70710-1716-5) / 112 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

70710-1716-4 1 BOTTLE, GLASS in 1 CARTON (70710-1716-4) / 112 mL in 1 BOTTLE, GLASS 70710-1716-5 1 BOTTLE, PLASTIC in 1 CARTON (70710-1716-5) / 112 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

sildenafil citrate (10 mg/mL)

Linked Drug Pages (1)

Sildenafil Citrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b42790ec-b9ad-4b34-b98d-dfb8d246eff2", "openfda": {"unii": ["BW9B0ZE037"], "rxcui": ["1307427"], "spl_set_id": ["b2f04ce4-f19c-403d-8a83-74f123e5d30a"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (70710-1716-4)  / 112 mL in 1 BOTTLE, GLASS", "package_ndc": "70710-1716-4", "marketing_start_date": "20221027"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (70710-1716-5)  / 112 mL in 1 BOTTLE, PLASTIC", "package_ndc": "70710-1716-5", "marketing_start_date": "20221027"}], "brand_name": "Sildenafil Citrate", "product_id": "70710-1716_b42790ec-b9ad-4b34-b98d-dfb8d246eff2", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "70710-1716", "generic_name": "Sildenafil Citrate", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sildenafil Citrate", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "10 mg/mL"}], "application_number": "ANDA215708", "marketing_category": "ANDA", "marketing_start_date": "20221027", "listing_expiration_date": "20271231"}