Sildenafil Citrate

Orange BookUNIISPLATC G04BE03

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

Identification

ManufacturerNuCare Pharmaceuticals,Inc.

CountryUS (United States)

ATC codeG04BE03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6807136313
30 TABLET, FILM COATED in 1 BOTTLE (68071-3631-3)

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": "68071-3631_1b1aaf1b-0e3f-915f-e063-6394a90a8dc5",
  "productndc": "68071-3631",
  "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": "50"
}

Related drugs

Other records sharing ATC code G04BE03.

Access this data programmatically

Query Sildenafil Citrate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs