Sildenafil

Orange BookUNIISPLATC G04BE03

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

Identification

ManufacturerNuCare Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeG04BE03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6807139789
90 TABLET, FILM COATED in 1 BOTTLE (68071-3978-9)

Annotations

UNII (FDA Substance ID)

BW9B0ZE037

SILDENAFIL CITRATE

RxCUI 221161

Orange Book

A202255

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": "68071-3978_4df499a6-8fe4-b392-e063-6394a90ae50d",
  "productndc": "68071-3978",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202255",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Apr 19, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Apr 19, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "Apr 19, 2023"
      }
    ],
    "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": "ANDA202255",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sildenafil",
  "start_marketing_date": "20230419",
  "active_numerator_strength": "50"
}

Related drugs

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