Back to search
🇺🇸

United States · US · US:0168-0258_e327c963-4ef7-4521-8a53-0c249cd21857

Clotrimazole and Betamethasone Dipropionate

Orange BookUNIISPLATC A07EA

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

Identification

ManufacturerE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
CountryUS (United States)
ATC codeA07EA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0168025815
    15 g in 1 TUBE (0168-0258-15)
  • ndc11
    0168025846
    45 g in 1 TUBE (0168-0258-46)

Annotations

UNII (FDA Substance ID)
826Y60901U
BETAMETHASONE DIPROPIONATE
RxCUI 19254
Orange Book
A075502
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "826Y60901U",
    "rxcui": "19254",
    "inchikey": "CIWBQSYVNNPZIQ-XYWKZLDCSA-N",
    "display_name": "BETAMETHASONE DIPROPIONATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "a6ac4020-2c67-426a-8289-7e54ce43d0c9": {
      "match": "brand_token",
      "title": "CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS PHARMA, INC.]",
      "spl_version": "15",
      "published_date": "2026-05-20"
    }
  },
  "productid": "0168-0258_e327c963-4ef7-4521-8a53-0c249cd21857",
  "productndc": "0168-0258",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "075502",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.05% BASE;1%",
        "product_no": "001",
        "approval_date": "Jun 5, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE",
  "proprietary_name": "Clotrimazole and Betamethasone Dipropionate",
  "active_ingred_unit": "mg/g; mg/g",
  "application_number": "ANDA075502",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clotrimazole and Betamethasone Dipropionate",
  "start_marketing_date": "20010605",
  "active_numerator_strength": ".5; 10"
}

Related drugs

Other records sharing ATC code A07EA.

Access this data programmatically

Query Clotrimazole and Betamethasone 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.