Calcitriol

In shortageOrange BookUNIISPLATC A11CC04

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

Identification

ManufacturerStrides Pharma Science Limited

CountryUS (United States)

ATC codeA11CC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6438072304
30 CAPSULE in 1 CONTAINER (64380-723-04)
ndc11
6438072306
100 CAPSULE in 1 CONTAINER (64380-723-06)

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": "64380-723_0c6ffbc5-f012-42c6-9847-c49e1708259b",
  "productndc": "64380-723",
  "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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