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United States · US · US:68462-298_2fc6dcb9-879f-4d6e-8194-4a30af922986

Clotrimazole and Betamethasone Dipropionate

Orange BookUNIISPLATC A07EA

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc. USA
CountryUS (United States)
ATC codeA07EA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6846229817
    15 g in 1 TUBE (68462-298-17)
  • ndc11
    6846229855
    45 g in 1 TUBE (68462-298-55)

Annotations

UNII (FDA Substance ID)
826Y60901U
BETAMETHASONE DIPROPIONATE
RxCUI 19254
Orange Book
A202894
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": "68462-298_2fc6dcb9-879f-4d6e-8194-4a30af922986",
  "productndc": "68462-298",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "202894",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.05% BASE;1%",
        "product_no": "001",
        "approval_date": "Oct 30, 2015"
      }
    ],
    "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": "ANDA202894",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clotrimazole and Betamethasone Dipropionate",
  "start_marketing_date": "20151106",
  "active_numerator_strength": ".5; 10"
}

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