Sildenafil Citrate

Orange BookUNIISPLATC G04BE03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeG04BE03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
7120530510
10 TABLET, FILM COATED in 1 BOTTLE (71205-305-10)
ndc11
7120530520
20 TABLET, FILM COATED in 1 BOTTLE (71205-305-20)
ndc11
7120530530
30 TABLET, FILM COATED in 1 BOTTLE (71205-305-30)
ndc11
7120530560
60 TABLET, FILM COATED in 1 BOTTLE (71205-305-60)
ndc11
7120530590
90 TABLET, FILM COATED in 1 BOTTLE (71205-305-90)

Annotations

UNII (FDA Substance ID)

BW9B0ZE037

SILDENAFIL CITRATE

RxCUI 221161

Orange Book

A204883

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "BW9B0ZE037",
    "rxcui": "221161",
    "inchikey": "DEIYFTQMQPDXOT-UHFFFAOYSA-N",
    "display_name": "SILDENAFIL CITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "78c4551c-b922-43c9-9a5a-66377ea07bc2": {
      "match": "brand_token",
      "title": "SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "24",
      "published_date": "2026-05-29"
    }
  },
  "productid": "71205-305_4f09b702-450f-4270-8e1a-2402677095cd",
  "productndc": "71205-305",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204883",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Jun 20, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SILDENAFIL CITRATE",
  "proprietary_name": "Sildenafil Citrate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204883",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sildenafil",
  "start_marketing_date": "20190101",
  "active_numerator_strength": "20"
}

Related drugs

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