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United States · US · US:69238-1574_87224b5f-b3ee-40e4-8ac1-45356a1b86eb

Sildenafil

Orange BookUNIISPLATC G04BE03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeG04BE03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6923815741
    1 BOTTLE, GLASS in 1 CARTON (69238-1574-1) / 112 mL in 1 BOTTLE, GLASS

Annotations

UNII (FDA Substance ID)
3M7OB98Y7H
SILDENAFIL
RxCUI 136411
Orange Book
A211092
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "3M7OB98Y7H",
    "rxcui": "136411",
    "inchikey": "BNRNXUUZRGQAQC-UHFFFAOYSA-N",
    "display_name": "SILDENAFIL",
    "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": "69238-1574_87224b5f-b3ee-40e4-8ac1-45356a1b86eb",
  "productndc": "69238-1574",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "211092",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE/ML",
        "product_no": "001",
        "approval_date": "Nov 27, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SILDENAFIL",
  "proprietary_name": "Sildenafil",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA211092",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sildenafil",
  "start_marketing_date": "20191206",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code G04BE03.

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