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United States · US · US:74676-0112_2bcfa6a9-635f-6bc9-ec72-839cca27541e

Tlando

In shortageOrange BookUNIISPLATC G03BA

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

Identification

ManufacturerVerity Pharmaceuticals Inc.
CountryUS (United States)
ATC codeG03BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7467601122
    120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (74676-0112-2)

Annotations

UNII (FDA Substance ID)
H16A5VCT9C
TESTOSTERONE UNDECANOATE
RxCUI 37864
Orange Book
N208088
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Testosterone Gel; Gel, Metered
Raw payload (JSON)
{
  "unii": {
    "unii": "H16A5VCT9C",
    "rxcui": "37864",
    "inchikey": "UDSFVOAUHKGBEK-CNQKSJKFSA-N",
    "display_name": "TESTOSTERONE UNDECANOATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "4b0b92e9-6d3c-a0e5-e1c7-342999f72580": {
      "match": "brand_token",
      "title": "TLANDO (TESTOSTERONE UNDECANOATE) CAPSULE, LIQUID FILLED [VERITY PHARMACEUTICALS INC.]",
      "spl_version": "5",
      "published_date": "2026-03-12"
    }
  },
  "productid": "74676-0112_2bcfa6a9-635f-6bc9-ec72-839cca27541e",
  "productndc": "74676-0112",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "208088",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "112.5MG",
        "product_no": "001",
        "approval_date": "Mar 28, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TESTOSTERONE UNDECANOATE",
  "shortage_reason": "Testosterone Gel; Gel, Metered",
  "shortage_status": "current",
  "proprietary_name": "Tlando",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA208088",
  "marketing_category": "NDA",
  "nonproprietary_name": "testosterone undecanoate",
  "start_marketing_date": "20220415",
  "active_numerator_strength": "112.5"
}

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