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United States · US · US:71205-220_5d593e03-b6f0-41d0-b7b2-e53d2421a903

Sildenafil

Orange BookUNIISPLATC G04BE03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeG04BE03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    7120522010
    10 TABLET, FILM COATED in 1 BOTTLE (71205-220-10)
  • ndc11
    7120522020
    20 TABLET, FILM COATED in 1 BOTTLE (71205-220-20)
  • ndc11
    7120522030
    30 TABLET, FILM COATED in 1 BOTTLE (71205-220-30)
  • ndc11
    7120522050
    50 TABLET, FILM COATED in 1 BOTTLE (71205-220-50)
  • ndc11
    7120522060
    60 TABLET, FILM COATED in 1 BOTTLE (71205-220-60)
  • ndc11
    7120522090
    90 TABLET, FILM COATED in 1 BOTTLE (71205-220-90)

Annotations

UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A203962
ABABAB
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": "71205-220_5d593e03-b6f0-41d0-b7b2-e53d2421a903",
  "productndc": "71205-220",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203962",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Jun 11, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Jun 11, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "Jun 11, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SILDENAFIL CITRATE",
  "proprietary_name": "Sildenafil",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203962",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sildenafil",
  "start_marketing_date": "20180611",
  "active_numerator_strength": "100"
}

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