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United States · US · US:62135-020_459c2035-71cd-e07e-e063-6394a90a5a3a

Hydrocortisone Rectal Suspension (Retention)

Orange BookUNIISPLATC A07EA02

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

Identification

ManufacturerChartwell RX LLC
CountryUS (United States)
ATC codeA07EA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6213502007
    7 BOTTLE in 1 CARTON (62135-020-07) / 60 mL in 1 BOTTLE
  • ndc11
    6213502021
    3 CARTON in 1 BOX (62135-020-21) / 7 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE
  • ndc11
    6213502046
    1 BOTTLE in 1 CARTON (62135-020-46) / 60 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
WI4X0X7BPJ
HYDROCORTISONE
RxCUI 5492
Orange Book
A075172
AB
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": "RECTAL",
  "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": "62135-020_459c2035-71cd-e07e-e063-6394a90a5a3a",
  "productndc": "62135-020",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "075172",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG/60ML",
        "product_no": "001",
        "approval_date": "Dec 3, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCORTISONE",
  "proprietary_name": "Hydrocortisone Rectal Suspension (Retention)",
  "active_ingred_unit": "mg/60mL",
  "application_number": "ANDA075172",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydrocortisone",
  "start_marketing_date": "19991203",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code A07EA02.

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