Back to search
🇺🇸

United States · US · US:70954-831_bdb9c0d4-bdb3-4174-a4d9-55c423f38476

Calcitriol

In shortageOrange BookUNIISPLATC A11CC04

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

Identification

ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA11CC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7095483110
    1 BOTTLE, GLASS in 1 CARTON (70954-831-10) / 15 mL in 1 BOTTLE, GLASS

Annotations

UNII (FDA Substance ID)
FXC9231JVH
CALCITRIOL
RxCUI 1894
Orange Book
N021068
AA
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": "70954-831_bdb9c0d4-bdb3-4174-a4d9-55c423f38476",
  "productndc": "70954-831",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "021068",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AA",
        "strength": "1MCG/ML",
        "product_no": "001",
        "approval_date": "Nov 20, 1998"
      }
    ],
    "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/mL",
  "application_number": "NDA021068",
  "marketing_category": "NDA",
  "nonproprietary_name": "Calcitriol",
  "start_marketing_date": "20260513",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code A11CC04.

Access this data programmatically

Query Calcitriol and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.