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United States · US · US:51672-1308_395c949b-3bfb-410d-e063-6394a90ad1d0

Clotrimazole and Betamethasone Dipropionate

Orange BookUNIISPLATC A07EA

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeA07EA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5167213083
    1 BOTTLE in 1 CARTON (51672-1308-3) / 30 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
826Y60901U
BETAMETHASONE DIPROPIONATE
RxCUI 19254
Orange Book
A076493
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": "51672-1308_395c949b-3bfb-410d-e063-6394a90ad1d0",
  "productndc": "51672-1308",
  "dosage_form": "LOTION",
  "orange_book": {
    "appl_no": "076493",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.05% BASE;1%",
        "product_no": "001",
        "approval_date": "Jul 28, 2004"
      }
    ],
    "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/mL; mg/mL",
  "application_number": "ANDA076493",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clotrimazole and Betamethasone Dipropionate",
  "start_marketing_date": "20040728",
  "active_numerator_strength": ".5; 10"
}

Related drugs

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