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United States · US · US:71335-1777_a509bbc3-0f61-4013-8a8f-77bb0cc4a019

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
    7133517770
    15 TABLET, FILM COATED in 1 BOTTLE (71335-1777-0)
  • ndc11
    7133517771
    10 TABLET, FILM COATED in 1 BOTTLE (71335-1777-1)
  • ndc11
    7133517772
    5 TABLET, FILM COATED in 1 BOTTLE (71335-1777-2)
  • ndc11
    7133517773
    30 TABLET, FILM COATED in 1 BOTTLE (71335-1777-3)
  • ndc11
    7133517774
    2 TABLET, FILM COATED in 1 BOTTLE (71335-1777-4)
  • ndc11
    7133517775
    6 TABLET, FILM COATED in 1 BOTTLE (71335-1777-5)
  • ndc11
    7133517776
    20 TABLET, FILM COATED in 1 BOTTLE (71335-1777-6)
  • ndc11
    7133517777
    4 TABLET, FILM COATED in 1 BOTTLE (71335-1777-7)
  • ndc11
    7133517778
    90 TABLET, FILM COATED in 1 BOTTLE (71335-1777-8)
  • ndc11
    7133517779
    60 TABLET, FILM COATED in 1 BOTTLE (71335-1777-9)

Annotations

UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A077342
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": "71335-1777_a509bbc3-0f61-4013-8a8f-77bb0cc4a019",
  "productndc": "71335-1777",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077342",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Mar 9, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Mar 9, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "Mar 9, 2016"
      }
    ],
    "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": "ANDA077342",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sildenafil",
  "start_marketing_date": "20171211",
  "active_numerator_strength": "100"
}

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