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United States · US · US:63629-7323_b5ca1280-996e-43d2-8e9a-657c0e9a4600

Calcitriol

In shortageOrange BookUNIISPLATC A11CC04

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeA11CC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6362973231
    30 CAPSULE in 1 BOTTLE (63629-7323-1)
  • ndc11
    6362973232
    28 CAPSULE in 1 BOTTLE (63629-7323-2)
  • ndc11
    6362973233
    90 CAPSULE in 1 BOTTLE (63629-7323-3)

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": "63629-7323_b5ca1280-996e-43d2-8e9a-657c0e9a4600",
  "productndc": "63629-7323",
  "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": "20141212",
  "active_numerator_strength": ".25"
}

Related drugs

Other records sharing ATC code A11CC04.

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