revatio

Generic: sildenafil citrate

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name revatio
Generic Name sildenafil citrate
Labeler viatris specialty llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

sildenafil citrate .8 mg/mL

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 58151-395
Product ID 58151-395_3fa2b889-ff04-4db1-b2c8-c0238efe240b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022473
Listing Expiration 2026-12-31
Marketing Start 2025-04-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58151395
Hyphenated Format 58151-395

Supplemental Identifiers

RxCUI
577033 581645 882527 882530 1307427 1307431
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 revatio (source: ndc)
Generic Name sildenafil citrate (source: ndc)
Application Number NDA022473 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .8 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (58151-395-31) / 12.5 mL in 1 VIAL
source: ndc

Packages (1)

58151-395-31 1 VIAL in 1 CARTON (58151-395-31) / 12.5 mL in 1 VIAL

Ingredients (1)

sildenafil citrate (.8 mg/mL)

Linked Drug Pages (1)

Revatio ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3fa2b889-ff04-4db1-b2c8-c0238efe240b", "openfda": {"unii": ["BW9B0ZE037"], "rxcui": ["577033", "581645", "882527", "882530", "1307427", "1307431"], "spl_set_id": ["3bb9363e-b28d-4019-8aae-539233dca214"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (58151-395-31)  / 12.5 mL in 1 VIAL", "package_ndc": "58151-395-31", "marketing_start_date": "20250409"}], "brand_name": "Revatio", "product_id": "58151-395_3fa2b889-ff04-4db1-b2c8-c0238efe240b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "58151-395", "generic_name": "sildenafil citrate", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Revatio", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": ".8 mg/mL"}], "application_number": "NDA022473", "marketing_category": "NDA", "marketing_start_date": "20250409", "listing_expiration_date": "20261231"}