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United States · US · US:71335-1638_68ec1574-866c-495a-a4e9-5631d24b2b04

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 · 9

  • ndc11
    7133516381
    10 TABLET, FILM COATED in 1 BOTTLE (71335-1638-1)
  • ndc11
    7133516382
    30 TABLET, FILM COATED in 1 BOTTLE (71335-1638-2)
  • ndc11
    7133516383
    7 TABLET, FILM COATED in 1 BOTTLE (71335-1638-3)
  • ndc11
    7133516384
    90 TABLET, FILM COATED in 1 BOTTLE (71335-1638-4)
  • ndc11
    7133516385
    60 TABLET, FILM COATED in 1 BOTTLE (71335-1638-5)
  • ndc11
    7133516386
    20 TABLET, FILM COATED in 1 BOTTLE (71335-1638-6)
  • ndc11
    7133516387
    270 TABLET, FILM COATED in 1 BOTTLE (71335-1638-7)
  • ndc11
    7133516388
    15 TABLET, FILM COATED in 1 BOTTLE (71335-1638-8)
  • ndc11
    7133516389
    12 TABLET, FILM COATED in 1 BOTTLE (71335-1638-9)

Annotations

UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A203814
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": "71335-1638_68ec1574-866c-495a-a4e9-5631d24b2b04",
  "productndc": "71335-1638",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203814",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Dec 17, 2013"
      }
    ],
    "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": "ANDA203814",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sildenafil",
  "start_marketing_date": "20140103",
  "active_numerator_strength": "20"
}

Related drugs

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