Calcitriol

In shortageOrange BookUNIISPLATC A11CC04

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeA11CC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7161087030
30 CAPSULE in 1 BOTTLE (71610-870-30)

Annotations

UNII (FDA Substance ID)

FXC9231JVH

CALCITRIOL

RxCUI 1894

Orange Book

A091356

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": "71610-870_29b8cf3d-3835-602b-e063-6294a90a89ce",
  "productndc": "71610-870",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "091356",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.25MCG",
        "product_no": "001",
        "approval_date": "Dec 12, 2014"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MCG",
        "product_no": "002",
        "approval_date": "Dec 12, 2014"
      }
    ],
    "appl_type": "A"
  },
  "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": "ANDA091356",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Calcitriol Capsules 0.25 mcg",
  "start_marketing_date": "20161210",
  "active_numerator_strength": ".25"
}

Related drugs

Other records sharing ATC code A11CC04.

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