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United States · US · US:0713-0849_106bf241-c85e-8985-e063-6394a90abffb

hydrocortisone and acetic acid

Orange BookUNIISPLATC G01AD

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

Identification

ManufacturerCosette Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG01AD
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0713084909
    1 BOTTLE in 1 CARTON (0713-0849-09) / 10 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
Q40Q9N063P
ACETIC ACID
RxCUI 168
Orange Book
A040609
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "Q40Q9N063P",
    "rxcui": "168",
    "inchikey": "QTBSBXVTEAMEQO-UHFFFAOYSA-N",
    "display_name": "ACETIC ACID",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "AURICULAR (OTIC)",
  "spl_meta": {
    "bc751403-94f2-4f9d-b533-cf6186a40ceb": {
      "match": "brand_token",
      "title": "HYDROCORTISONE TABLET [MYLAN PHARMACEUTICALS INC.]",
      "spl_version": "12",
      "published_date": "2026-05-27"
    }
  },
  "productid": "0713-0849_106bf241-c85e-8985-e063-6394a90abffb",
  "productndc": "0713-0849",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "040609",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "2%;1%",
        "product_no": "001",
        "approval_date": "Feb 6, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETIC ACID; HYDROCORTISONE",
  "proprietary_name": "hydrocortisone and acetic acid",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "ANDA040609",
  "marketing_category": "ANDA",
  "nonproprietary_name": "hydrocortisone and acetic acid",
  "start_marketing_date": "20240201",
  "active_numerator_strength": "20; 10"
}

Related drugs

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