sildenafil

Generic: sildenafil citrate

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sildenafil
Generic Name sildenafil citrate
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

sildenafil citrate 10 mg/12.5mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-166
Product ID 55150-166_c6f23ad9-ca87-47a3-8d85-dfc334e5a91b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203988
Listing Expiration 2026-12-31
Marketing Start 2015-04-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150166
Hyphenated Format 55150-166

Supplemental Identifiers

RxCUI
882527
UPC
0355150166138
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 citrate (source: ndc)
Application Number ANDA203988 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/12.5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-166-13) / 12.5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-166-13 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-166-13) / 12.5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

sildenafil citrate (10 mg/12.5mL)

Linked Drug Pages (1)

Sildenafil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c6f23ad9-ca87-47a3-8d85-dfc334e5a91b", "openfda": {"upc": ["0355150166138"], "unii": ["BW9B0ZE037"], "rxcui": ["882527"], "spl_set_id": ["bb92d686-a81e-4b91-8048-693af0534cb3"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55150-166-13)  / 12.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-166-13", "marketing_start_date": "20150401"}], "brand_name": "Sildenafil", "product_id": "55150-166_c6f23ad9-ca87-47a3-8d85-dfc334e5a91b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "55150-166", "generic_name": "Sildenafil Citrate", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sildenafil", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "10 mg/12.5mL"}], "application_number": "ANDA203988", "marketing_category": "ANDA", "marketing_start_date": "20150401", "listing_expiration_date": "20261231"}