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United States · US · US:27241-069_693e54c2-18ce-4ef0-8b65-894bff61dd9e

Sildenafil Citrate

Orange BookUNIISPLATC G04BE03

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

Identification

ManufacturerAjanta Pharma USA Inc.
CountryUS (United States)
ATC codeG04BE03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    2724106903
    30 TABLET, FILM COATED in 1 BOTTLE (27241-069-03)
  • ndc11
    2724106905
    500 TABLET, FILM COATED in 1 BOTTLE (27241-069-05)
  • ndc11
    2724106910
    100 TABLET, FILM COATED in 1 BOTTLE (27241-069-10)

Annotations

UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A206401
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": "27241-069_693e54c2-18ce-4ef0-8b65-894bff61dd9e",
  "productndc": "27241-069",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "206401",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Oct 12, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Oct 12, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "Oct 12, 2018"
      }
    ],
    "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": "ANDA206401",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sildenafil",
  "start_marketing_date": "20181012",
  "active_numerator_strength": "100"
}

Related drugs

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