CALCITRIOL

In shortageOrange BookUNIISPLATC A11CC04

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeA11CC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6330424001
100 CAPSULE in 1 BOTTLE (63304-240-01)

Annotations

UNII (FDA Substance ID)

FXC9231JVH

CALCITRIOL

RxCUI 1894

Orange Book

N018044

ABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Calcitriol Capsule

Raw payload (JSON)

{
  "unii": {
    "unii": "FXC9231JVH",
    "rxcui": "1894",
    "inchikey": "GMRQFYUYWCNGIN-NKMMMXOESA-N",
    "display_name": "CALCITRIOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "bdb9c0d4-bdb3-4174-a4d9-55c423f38476": {
      "match": "brand_token",
      "title": "CALCITRIOL SOLUTION [ANI PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2026-05-15"
    }
  },
  "productid": "63304-240_ccc0e02b-bd1e-45f2-9256-6933ac193518",
  "productndc": "63304-240",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "018044",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.25MCG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.5MCG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CALCITRIOL",
  "shortage_reason": "Calcitriol Capsule",
  "shortage_status": "current",
  "proprietary_name": "CALCITRIOL",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA018044",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "CALCITRIOL",
  "start_marketing_date": "20090826",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code A11CC04.

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