sildenafil

Generic: sildenafil

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

Drug Facts

Product Profile

Brand Name sildenafil
Generic Name sildenafil
Labeler lupin pharmaceuticals, inc.
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

sildenafil citrate 10 mg/mL

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-283
Product ID 68180-283_18727593-f734-4bd5-88eb-625779d35660
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211638
Listing Expiration 2026-12-31
Marketing Start 2022-09-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180283
Hyphenated Format 68180-283

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 ANDA211638 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68180-283-01) / 112 mL in 1 BOTTLE
source: ndc

Packages (1)

68180-283-01 1 BOTTLE in 1 CARTON (68180-283-01) / 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": "18727593-f734-4bd5-88eb-625779d35660", "openfda": {"unii": ["BW9B0ZE037"], "rxcui": ["1307427"], "spl_set_id": ["407ee7fc-0022-4fac-9fa6-4285d774fdb3"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68180-283-01)  / 112 mL in 1 BOTTLE", "package_ndc": "68180-283-01", "marketing_start_date": "20220928"}], "brand_name": "SILDENAFIL", "product_id": "68180-283_18727593-f734-4bd5-88eb-625779d35660", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "68180-283", "generic_name": "Sildenafil", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SILDENAFIL", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "10 mg/mL"}], "application_number": "ANDA211638", "marketing_category": "ANDA", "marketing_start_date": "20220928", "listing_expiration_date": "20261231"}