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United States · US · US:31722-136_1389f9d0-c617-8381-e063-6394a90a7a76

Sildenafil

Orange BookUNIISPLATC G04BE03

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

Identification

ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG04BE03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3172213631
    1 BOTTLE, GLASS in 1 CARTON (31722-136-31) / 112 mL in 1 BOTTLE, GLASS

Annotations

UNII (FDA Substance ID)
BW9B0ZE037
SILDENAFIL CITRATE
RxCUI 221161
Orange Book
A213014
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": "31722-136_1389f9d0-c617-8381-e063-6394a90a7a76",
  "productndc": "31722-136",
  "dosage_form": "FOR SUSPENSION",
  "orange_book": {
    "appl_no": "213014",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE/ML",
        "product_no": "001",
        "approval_date": "May 11, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SILDENAFIL CITRATE",
  "proprietary_name": "Sildenafil",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA213014",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sildenafil Powder,",
  "start_marketing_date": "20210511",
  "active_numerator_strength": "10"
}

Related drugs

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