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United States · US · US:27241-124_f5da6ecc-eebe-409e-9251-869a73ef4d4e

Sildenafil

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 · 2

  • ndc11
    2724112403
    90 TABLET in 1 BOTTLE (27241-124-03)
  • ndc11
    2724112405
    500 TABLET in 1 BOTTLE (27241-124-05)

Annotations

UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A210394
AB
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": "27241-124_f5da6ecc-eebe-409e-9251-869a73ef4d4e",
  "productndc": "27241-124",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "210394",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "May 4, 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": "ANDA210394",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sildenafil",
  "start_marketing_date": "20180504",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code G04BE03.

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