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United States · US · US:35561-257_49fc9e85-3dc2-064f-e063-6294a90af582

N/A

Orange BookUNIISPLATC G04BE08

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

Identification

ManufacturerBostal LLC
CountryUS (United States)
ATC codeG04BE08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    3556125710
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-257-10)
  • ndc11
    3556125713
    500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-257-13)

Annotations

UNII (FDA Substance ID)
742SXX0ICT
TADALAFIL
RxCUI 358263
Orange Book
A208824
AB1AB1AB1AB1
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "742SXX0ICT",
    "rxcui": "358263",
    "inchikey": "WOXKDUGGOYFFRN-IIBYNOLFSA-N",
    "display_name": "TADALAFIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "4a4fa6e8-0e0a-0e76-e054-00144ff8d46c": {
      "match": "brand_token",
      "title": "N/A (ATROPINE SULFATE INJECTION USP, 1 MG/0.7 ML) INJECTION N/A (ATROPINE SULFATE INJECTION USP, 0.5 MG/0.7 ML) INJECTION N/A (ATROPINE INJECTION, 2 MG) INJECTION [RAFA LABORATORIES, LTD.]",
      "spl_version": "8",
      "published_date": "2026-02-19"
    }
  },
  "productid": "35561-257_49fc9e85-3dc2-064f-e063-6294a90af582",
  "productndc": "35561-257",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208824",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Oct 27, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Oct 27, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Oct 27, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "20MG",
        "product_no": "004",
        "approval_date": "Oct 27, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TADALAFIL",
  "proprietary_name": "N/A",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208824",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tadalafil",
  "start_marketing_date": "20191129",
  "active_numerator_strength": "20"
}

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