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United States · US · US:65162-576_ef9469b2-7a07-48f6-b7be-8a8ae57f08e4

Calcitriol

In shortageOrange BookUNIISPLATC A11CC04

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

Identification

ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeA11CC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6516257603
    30 CAPSULE in 1 BOTTLE (65162-576-03)
  • ndc11
    6516257610
    100 CAPSULE in 1 BOTTLE (65162-576-10)
  • ndc11
    6516257625
    250 CAPSULE in 1 BOTTLE (65162-576-25)

Annotations

UNII (FDA Substance ID)
FXC9231JVH
CALCITRIOL
RxCUI 1894
Orange Book
A203289
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": "65162-576_ef9469b2-7a07-48f6-b7be-8a8ae57f08e4",
  "productndc": "65162-576",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "203289",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MCG",
        "product_no": "001",
        "approval_date": "Jun 14, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.25MCG",
        "product_no": "002",
        "approval_date": "Jun 14, 2017"
      }
    ],
    "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": "ANDA203289",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Calcitriol",
  "start_marketing_date": "20170618",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code A11CC04.

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