Alacort

Orange BookUNIISPLATC A07EA02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerCrown Laboratories

CountryUS (United States)

ATC codeA07EA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
0316012816
454 g in 1 JAR (0316-0128-16)
ndc11
0316012820
1 TUBE in 1 CARTON (0316-0128-20) / 20 g in 1 TUBE
ndc11
0316012830
1 TUBE in 1 CARTON (0316-0128-30) / 30 g in 1 TUBE

Annotations

UNII (FDA Substance ID)

WI4X0X7BPJ

HYDROCORTISONE

RxCUI 5492

Orange Book

A080706

ATAT

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "WI4X0X7BPJ",
    "rxcui": "5492",
    "inchikey": "JYGXADMDTFJGBT-VWUMJDOOSA-N",
    "display_name": "HYDROCORTISONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "de000081-a245-4f6b-9e7c-e47d84b82338": {
      "match": "brand_token",
      "title": "ALACORT (HYDROCORTISONE) CREAM [CROWN LABORATORIES]",
      "spl_version": "20",
      "published_date": "2026-01-14"
    }
  },
  "productid": "0316-0128_48343dfa-8e9e-5f2c-e063-6294a90a72db",
  "productndc": "0316-0128",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "080706",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "1%",
        "product_no": "006",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "2.5%",
        "product_no": "007",
        "approval_date": "Jan 5, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCORTISONE",
  "proprietary_name": "Alacort",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA080706",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrocortisone",
  "start_marketing_date": "20160106",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code A07EA02.

Access this data programmatically

Query Alacort and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs