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United States · US · US:63629-7833_d46344f0-a486-4a8b-b941-bf03c75aa7b3

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 · 7

  • ndc11
    6362978331
    30 TABLET, FILM COATED in 1 BOTTLE (63629-7833-1)
  • ndc11
    6362978332
    10 TABLET, FILM COATED in 1 BOTTLE (63629-7833-2)
  • ndc11
    6362978333
    15 TABLET, FILM COATED in 1 BOTTLE (63629-7833-3)
  • ndc11
    6362978334
    90 TABLET, FILM COATED in 1 BOTTLE (63629-7833-4)
  • ndc11
    6362978335
    60 TABLET, FILM COATED in 1 BOTTLE (63629-7833-5)
  • ndc11
    6362978336
    20 TABLET, FILM COATED in 1 BOTTLE (63629-7833-6)
  • ndc11
    6362978337
    7 TABLET, FILM COATED in 1 BOTTLE (63629-7833-7)

Annotations

UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A202023
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": "63629-7833_d46344f0-a486-4a8b-b941-bf03c75aa7b3",
  "productndc": "63629-7833",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202023",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Jun 27, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Jun 27, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "Jun 27, 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": "ANDA202023",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sildenafil",
  "start_marketing_date": "20180628",
  "active_numerator_strength": "50"
}

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