SILDENAFIL CITRATE

Orange BookUNIISPLATC G04BE03

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

Identification

ManufacturerNorthstar Rx LLC

CountryUS (United States)

ATC codeG04BE03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7260388301
30 TABLET in 1 BOTTLE (72603-883-01)

Annotations

UNII (FDA Substance ID)

BW9B0ZE037

SILDENAFIL CITRATE

RxCUI 221161

Orange Book

A209302

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": "72603-883_4bb9baea-3bd6-03c0-e063-6294a90a218a",
  "productndc": "72603-883",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209302",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Aug 25, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "002",
        "approval_date": "Aug 25, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "003",
        "approval_date": "Jun 15, 2021"
      }
    ],
    "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": "ANDA209302",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SILDENAFIL CITRATE",
  "start_marketing_date": "20260224",
  "active_numerator_strength": "25"
}

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