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United States · US · US:70771-1668_37e37cf7-663e-45b8-8056-596b5fb6ac63

Sildenafil Citrate

Orange BookUNIISPLATC G04BE03

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeG04BE03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7077116684
    1 BOTTLE, GLASS in 1 CARTON (70771-1668-4) / 112 mL in 1 BOTTLE, GLASS
  • ndc11
    7077116685
    1 BOTTLE, PLASTIC in 1 CARTON (70771-1668-5) / 112 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A215708
AB
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": "70771-1668_37e37cf7-663e-45b8-8056-596b5fb6ac63",
  "productndc": "70771-1668",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "215708",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE/ML",
        "product_no": "001",
        "approval_date": "Sep 29, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SILDENAFIL CITRATE",
  "proprietary_name": "Sildenafil Citrate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA215708",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sildenafil Citrate",
  "start_marketing_date": "20221027",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code G04BE03.

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