Back to search
🇺🇸

United States · US · US:51672-1335_3961db48-e5fb-c2d8-e063-6294a90ab8ba

Oralone

In shortageOrange BookUNIISPLATC A01AC

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeA01AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5167213355
    1 TUBE in 1 CARTON (51672-1335-5) / 5 g in 1 TUBE
  • ndc11
    5167213358
    1 TUBE in 1 CARTON (51672-1335-8) / 7.5 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
F446C597KA
TRIAMCINOLONE ACETONIDE
RxCUI 10761
Orange Book
A070730
AT
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Triamcinolone Hexacetonide Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "F446C597KA",
    "rxcui": "10761",
    "inchikey": "YNDXUCZADRHECN-JNQJZLCISA-N",
    "display_name": "TRIAMCINOLONE ACETONIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "DENTAL",
  "spl_meta": {
    "ac1e2116-795e-4c20-974d-11fa07cf0fa7": {
      "match": "brand_token",
      "title": "ORALONE (TRIAMCINOLONE ACETONIDE) PASTE [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "4",
      "published_date": "2025-07-09"
    }
  },
  "productid": "51672-1335_3961db48-e5fb-c2d8-e063-6294a90ab8ba",
  "productndc": "51672-1335",
  "dosage_form": "PASTE",
  "orange_book": {
    "appl_no": "070730",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AT",
        "strength": "0.1%",
        "product_no": "001",
        "approval_date": "Oct 1, 1986"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRIAMCINOLONE ACETONIDE",
  "shortage_reason": "Triamcinolone Hexacetonide Injection",
  "shortage_status": "current",
  "proprietary_name": "Oralone",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA070730",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Triamcinolone Acetonide",
  "start_marketing_date": "19861001",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code A01AC.

Access this data programmatically

Query Oralone and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.