Avanafil

Orange BookUNIISPLATC G04BE10

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

Identification

ManufacturerCamber Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeG04BE10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
3172244101
100 TABLET in 1 BOTTLE (31722-441-01)
ndc11
3172244130
30 TABLET in 1 BOTTLE (31722-441-30)

Annotations

UNII (FDA Substance ID)

DR5S136IVO

AVANAFIL

RxCUI 1291301

Orange Book

A209266

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "DR5S136IVO",
    "rxcui": "1291301",
    "inchikey": "WEAJZXNPAWBCOA-INIZCTEOSA-N",
    "display_name": "AVANAFIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "1d04e17d-7399-430a-a8bb-fa1912b155e9": {
      "match": "brand_token",
      "title": "AVANAFIL (AVANAFIL) TABLET [CAMBER PHARMACEUTICALS, INC.]",
      "spl_version": "2",
      "published_date": "2025-12-19"
    }
  },
  "productid": "31722-441_46258a47-8730-8397-e063-6394a90a6478",
  "productndc": "31722-441",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209266",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jun 14, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Jun 14, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Jun 14, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AVANAFIL",
  "proprietary_name": "Avanafil",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209266",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Avanafil",
  "start_marketing_date": "20240614",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code G04BE10.

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