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United States · US · US:66887-001_366a5e88-4a23-46b0-94e5-e7f7deb7acbe

Testim

In shortageOrange BookUNIISPLATC G03BA03

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

Identification

ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeG03BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6688700105
    30 TUBE in 1 CARTON (66887-001-05) / 5 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
3XMK78S47O
TESTOSTERONE
RxCUI 10379
Orange Book
N021454
AB2
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Testosterone Gel; Gel, Metered
Raw payload (JSON)
{
  "unii": {
    "unii": "3XMK78S47O",
    "rxcui": "10379",
    "inchikey": "MUMGGOZAMZWBJJ-DYKIIFRCSA-N",
    "display_name": "TESTOSTERONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TRANSDERMAL",
  "spl_meta": {
    "9f2aae1f-898d-4955-be31-678e0cf85395": {
      "match": "brand_token",
      "title": "TESTIM (TESTOSTERONE) GEL [ENDO USA, INC.]",
      "spl_version": "29",
      "published_date": "2026-03-05"
    }
  },
  "productid": "66887-001_366a5e88-4a23-46b0-94e5-e7f7deb7acbe",
  "productndc": "66887-001",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "021454",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB2",
        "strength": "50MG/5GM PACKET",
        "product_no": "001",
        "approval_date": "Oct 31, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TESTOSTERONE",
  "shortage_reason": "Testosterone Gel; Gel, Metered",
  "shortage_status": "current",
  "proprietary_name": "Testim",
  "active_ingred_unit": "mg/5g",
  "application_number": "NDA021454",
  "marketing_category": "NDA",
  "nonproprietary_name": "testosterone",
  "start_marketing_date": "20021031",
  "active_numerator_strength": "50"
}

Related drugs

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