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United States · US · US:71610-675_f4dbdb1b-c31d-4418-abd9-883eef04d5bd

SILDENAFIL

Orange BookUNIISPLATC G04BE03

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeG04BE03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    7161067502
    2 TABLET in 1 BOTTLE (71610-675-02)
  • ndc11
    7161067503
    9 TABLET in 1 BOTTLE (71610-675-03)
  • ndc11
    7161067504
    4 TABLET in 1 BOTTLE (71610-675-04)
  • ndc11
    7161067506
    6 TABLET in 1 BOTTLE (71610-675-06)
  • ndc11
    7161067512
    12 TABLET in 1 BOTTLE (71610-675-12)
  • ndc11
    7161067533
    3 TABLET in 1 BOTTLE (71610-675-33)
  • ndc11
    7161067552
    18 TABLET in 1 BOTTLE (71610-675-52)

Annotations

UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A207178
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": "71610-675_f4dbdb1b-c31d-4418-abd9-883eef04d5bd",
  "productndc": "71610-675",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207178",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Mar 2, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Mar 2, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "Mar 2, 2020"
      }
    ],
    "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": "ANDA207178",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SILDENAFIL",
  "start_marketing_date": "20220701",
  "active_numerator_strength": "100"
}

Related drugs

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