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United States · US · US:71335-2723_78524f12-bfd2-4f0a-9340-a7c4d0df02c5

hydrocortisone valerate cream

Orange BookUNIISPLATC A07EA02

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeA07EA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7133527231
    1 TUBE in 1 CARTON (71335-2723-1) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
68717P8FUZ
HYDROCORTISONE VALERATE
RxCUI 27199
Orange Book
A211047
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "68717P8FUZ",
    "rxcui": "27199",
    "inchikey": "FZCHYNWYXKICIO-FZNHGJLXSA-N",
    "display_name": "HYDROCORTISONE VALERATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "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": "71335-2723_78524f12-bfd2-4f0a-9340-a7c4d0df02c5",
  "productndc": "71335-2723",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "211047",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.2%",
        "product_no": "001",
        "approval_date": "Nov 4, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCORTISONE VALERATE",
  "proprietary_name": "hydrocortisone valerate cream",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA211047",
  "marketing_category": "ANDA",
  "nonproprietary_name": "hydrocortisone valerate cream",
  "start_marketing_date": "20221231",
  "active_numerator_strength": "2"
}

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