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United States · US · US:71335-1963_8cf40711-534a-4663-9a3b-d92dcc1fe0e9

Sildenafil

Orange BookUNIISPLATC G04BE03

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeG04BE03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 10

  • ndc11
    7133519630
    50 TABLET in 1 BOTTLE (71335-1963-0)
  • ndc11
    7133519631
    10 TABLET in 1 BOTTLE (71335-1963-1)
  • ndc11
    7133519632
    30 TABLET in 1 BOTTLE (71335-1963-2)
  • ndc11
    7133519633
    7 TABLET in 1 BOTTLE (71335-1963-3)
  • ndc11
    7133519634
    90 TABLET in 1 BOTTLE (71335-1963-4)
  • ndc11
    7133519635
    60 TABLET in 1 BOTTLE (71335-1963-5)
  • ndc11
    7133519636
    20 TABLET in 1 BOTTLE (71335-1963-6)
  • ndc11
    7133519637
    270 TABLET in 1 BOTTLE (71335-1963-7)
  • ndc11
    7133519638
    15 TABLET in 1 BOTTLE (71335-1963-8)
  • ndc11
    7133519639
    12 TABLET in 1 BOTTLE (71335-1963-9)

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": "71335-1963_8cf40711-534a-4663-9a3b-d92dcc1fe0e9",
  "productndc": "71335-1963",
  "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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