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United States · US · US:76420-613_05373fec-0f63-7fd4-e063-6394a90af72d

SILDENAFIL CITRATE

Orange BookUNIISPLATC G04BE03

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

Identification

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

Packs · 3

  • ndc11
    7642061330
    30 TABLET in 1 BOTTLE (76420-613-30)
  • ndc11
    7642061360
    60 TABLET in 1 BOTTLE (76420-613-60)
  • ndc11
    7642061390
    90 TABLET in 1 BOTTLE (76420-613-90)

Annotations

UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A091479
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": "76420-613_05373fec-0f63-7fd4-e063-6394a90af72d",
  "productndc": "76420-613",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "091479",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Nov 6, 2012"
      }
    ],
    "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": "ANDA091479",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SILDENAFIL CITRATE",
  "start_marketing_date": "20121106",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code G04BE03.

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