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United States · US · US:51672-1290_39628349-b388-4030-e063-6394a90a6ce9

Hydrocortisone Valerate

Orange BookUNIISPLATC A07EA02

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeA07EA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5167212901
    1 TUBE in 1 CARTON (51672-1290-1) / 15 g in 1 TUBE
  • ndc11
    5167212903
    1 TUBE in 1 CARTON (51672-1290-3) / 60 g in 1 TUBE
  • ndc11
    5167212906
    1 TUBE in 1 CARTON (51672-1290-6) / 45 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
68717P8FUZ
HYDROCORTISONE VALERATE
RxCUI 27199
Orange Book
A075042
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": "51672-1290_39628349-b388-4030-e063-6394a90a6ce9",
  "productndc": "51672-1290",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "075042",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.2%",
        "product_no": "001",
        "approval_date": "Aug 25, 1998"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCORTISONE VALERATE",
  "proprietary_name": "Hydrocortisone Valerate",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA075042",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrocortisone Valerate",
  "start_marketing_date": "19980825",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code A07EA02.

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