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 · 10

ndc11
7133514370
15 TABLET, FILM COATED in 1 BOTTLE (71335-1437-0)
ndc11
7133514371
10 TABLET, FILM COATED in 1 BOTTLE (71335-1437-1)
ndc11
7133514372
5 TABLET, FILM COATED in 1 BOTTLE (71335-1437-2)
ndc11
7133514373
30 TABLET, FILM COATED in 1 BOTTLE (71335-1437-3)
ndc11
7133514374
2 TABLET, FILM COATED in 1 BOTTLE (71335-1437-4)
ndc11
7133514375
6 TABLET, FILM COATED in 1 BOTTLE (71335-1437-5)
ndc11
7133514376
20 TABLET, FILM COATED in 1 BOTTLE (71335-1437-6)
ndc11
7133514377
4 TABLET, FILM COATED in 1 BOTTLE (71335-1437-7)
ndc11
7133514378
90 TABLET, FILM COATED in 1 BOTTLE (71335-1437-8)
ndc11
7133514379
60 TABLET, FILM COATED in 1 BOTTLE (71335-1437-9)

Annotations

UNII (FDA Substance ID)

BW9B0ZE037

SILDENAFIL CITRATE

RxCUI 221161

Orange Book

A206401

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": "71335-1437_7d482029-8619-45c8-bf0d-33af01a33d66",
  "productndc": "71335-1437",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "206401",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Oct 12, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Oct 12, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "Oct 12, 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": "ANDA206401",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sildenafil",
  "start_marketing_date": "20181012",
  "active_numerator_strength": "100"
}

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