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United States · US · US:21130-825_8fb5cd26-54da-4d81-943b-1b029706e77a

signature care miconazole 7

Orange BookUNIISPLATC G01AF04

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

Identification

ManufacturerSafeway
CountryUS (United States)
ATC codeG01AF04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2113082529
    1 TUBE, WITH APPLICATOR in 1 CARTON (21130-825-29) / 45 g in 1 TUBE, WITH APPLICATOR

Annotations

UNII (FDA Substance ID)
VW4H1CYW1K
MICONAZOLE NITRATE
RxCUI 42790
Orange Book
A074760
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "VW4H1CYW1K",
    "rxcui": "42790",
    "inchikey": "MCCACAIVAXEFAL-UHFFFAOYSA-N",
    "display_name": "MICONAZOLE NITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "VAGINAL",
  "spl_meta": {
    "4f555b8f-5193-e685-e063-6294a90a7ba2": {
      "match": "brand_token",
      "title": "SIGNATURE PAIN RELIEF CREAM (4% LIDOCAINE) CREAM [SHENGNAN (GUANGZHOU) COSMETICS CO., LTD]",
      "spl_version": "1",
      "published_date": "2026-04-14"
    }
  },
  "productid": "21130-825_8fb5cd26-54da-4d81-943b-1b029706e77a",
  "productndc": "21130-825",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "074760",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2%",
        "product_no": "001",
        "approval_date": "May 15, 1997"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "MICONAZOLE NITRATE",
  "proprietary_name": "signature care miconazole 7",
  "active_ingred_unit": "g/100g",
  "application_number": "ANDA074760",
  "marketing_category": "ANDA",
  "nonproprietary_name": "miconazole nitrate",
  "start_marketing_date": "20181106",
  "active_numerator_strength": "2"
}

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