SILDENAFIL CITRATE

Orange BookUNIISPLATC G04BE03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeG04BE03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
7133531111
30 TABLET, FILM COATED in 1 BOTTLE (71335-3111-1)
ndc11
7133531112
10 TABLET, FILM COATED in 1 BOTTLE (71335-3111-2)
ndc11
7133531113
15 TABLET, FILM COATED in 1 BOTTLE (71335-3111-3)
ndc11
7133531114
90 TABLET, FILM COATED in 1 BOTTLE (71335-3111-4)
ndc11
7133531115
60 TABLET, FILM COATED in 1 BOTTLE (71335-3111-5)
ndc11
7133531116
20 TABLET, FILM COATED in 1 BOTTLE (71335-3111-6)
ndc11
7133531117
7 TABLET, FILM COATED in 1 BOTTLE (71335-3111-7)
ndc11
7133531118
40 TABLET, FILM COATED in 1 BOTTLE (71335-3111-8)

Annotations

UNII (FDA Substance ID)

BW9B0ZE037

SILDENAFIL CITRATE

RxCUI 221161

Orange Book

A091448

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": "71335-3111_8dfbbbc6-2ad4-4aaa-a7ec-17dc31e3efd3",
  "productndc": "71335-3111",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "091448",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Jun 11, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Jun 11, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "Jun 11, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SILDENAFIL CITRATE",
  "proprietary_name": "SILDENAFIL CITRATE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091448",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SILDENAFIL",
  "start_marketing_date": "20180611",
  "active_numerator_strength": "50"
}

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