Calcitriol

In shortageOrange BookUNIISPLATC A11CC04

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.

CountryUS (United States)

ATC codeA11CC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0093735301
100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0093-7353-01)

Annotations

UNII (FDA Substance ID)

FXC9231JVH

CALCITRIOL

RxCUI 1894

Orange Book

A075765

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": "0093-7353_9e6df585-e3d1-4a89-bc02-8e4b223578c4",
  "productndc": "0093-7353",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "075765",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.25MCG",
        "product_no": "001",
        "approval_date": "Oct 12, 2001"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MCG",
        "product_no": "002",
        "approval_date": "Oct 12, 2001"
      }
    ],
    "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": "ANDA075765",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Calcitriol",
  "start_marketing_date": "20160701",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code A11CC04.

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