Back to search
🇺🇸

United States · US · US:0168-0263_901e10b7-2784-49c4-8e56-1c461aaad927

Alclometasone Dipropionate

Orange BookUNIISPLATC D07AB10

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

Identification

ManufacturerE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
CountryUS (United States)
ATC codeD07AB10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0168026315
    15 g in 1 TUBE (0168-0263-15)
  • ndc11
    0168026345
    45 g in 1 TUBE (0168-0263-45)
  • ndc11
    0168026360
    60 g in 1 TUBE (0168-0263-60)

Annotations

UNII (FDA Substance ID)
S56PQL4N1V
ALCLOMETASONE DIPROPIONATE
RxCUI 17268
Orange Book
A076973
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "S56PQL4N1V",
    "rxcui": "17268",
    "inchikey": "DJHCCTTVDRAMEH-DUUJBDRPSA-N",
    "display_name": "ALCLOMETASONE DIPROPIONATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "3b0dccd6-dee1-49dd-8c6d-82df5c7ee36c": {
      "match": "brand_token",
      "title": "ALCLOMETASONE DIPROPIONATE OINTMENT [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "6",
      "published_date": "2025-08-15"
    }
  },
  "productid": "0168-0263_901e10b7-2784-49c4-8e56-1c461aaad927",
  "productndc": "0168-0263",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "076973",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "Jul 12, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALCLOMETASONE DIPROPIONATE",
  "proprietary_name": "Alclometasone Dipropionate",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA076973",
  "marketing_category": "ANDA",
  "nonproprietary_name": "alclometasone dipropionate",
  "start_marketing_date": "20050712",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code D07AB10.

Access this data programmatically

Query Alclometasone Dipropionate 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.