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United States · US · US:72789-406_31f7b5b5-476d-0490-e063-6394a90a88f2

SILDENAFIL CITRATE

Orange BookUNIISPLATC G04BE03

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG04BE03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7278940615
    15 TABLET in 1 BOTTLE, PLASTIC (72789-406-15)
  • ndc11
    7278940630
    30 TABLET in 1 BOTTLE, PLASTIC (72789-406-30)
  • ndc11
    7278940690
    90 TABLET in 1 BOTTLE, PLASTIC (72789-406-90)

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": "72789-406_31f7b5b5-476d-0490-e063-6394a90a88f2",
  "productndc": "72789-406",
  "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": "20200904",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code G04BE03.

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