sildenafil

Generic: sildenafil

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sildenafil
Generic Name sildenafil
Labeler bluepoint laboratories
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sildenafil citrate 20 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-597
Product ID 68001-597_28da809a-99b6-e220-e063-6294a90ac8ae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203814
Listing Expiration 2026-12-31
Marketing Start 2023-06-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001597
Hyphenated Format 68001-597

Supplemental Identifiers

RxCUI
577033
UPC
0368001597050 0368001363051
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 ANDA203814 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (68001-597-05)
source: ndc

Packages (1)

68001-597-05 90 TABLET, FILM COATED in 1 BOTTLE (68001-597-05)

Ingredients (1)

sildenafil citrate (20 mg/1)

Linked Drug Pages (1)

Sildenafil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "28da809a-99b6-e220-e063-6294a90ac8ae", "openfda": {"upc": ["0368001597050", "0368001363051"], "unii": ["BW9B0ZE037"], "rxcui": ["577033"], "spl_set_id": ["be6d1015-306d-44fb-8d4d-01724b8d9590"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68001-597-05)", "package_ndc": "68001-597-05", "marketing_start_date": "20230612"}], "brand_name": "Sildenafil", "product_id": "68001-597_28da809a-99b6-e220-e063-6294a90ac8ae", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphodiesterase 5 Inhibitor [EPC]", "Phosphodiesterase 5 Inhibitors [MoA]"], "product_ndc": "68001-597", "generic_name": "Sildenafil", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sildenafil", "active_ingredients": [{"name": "SILDENAFIL CITRATE", "strength": "20 mg/1"}], "application_number": "ANDA203814", "marketing_category": "ANDA", "marketing_start_date": "20230612", "listing_expiration_date": "20261231"}