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United States · US · US:63323-130_b4654993-19ce-4911-a0d0-4836f357223d

Doxy 100

In shortageOrange BookUNIISPLATC A01AB

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeA01AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6332313013
    10 VIAL in 1 TRAY (63323-130-13) / 10 mL in 1 VIAL (63323-130-03)

Annotations

UNII (FDA Substance ID)
19XTS3T51U
DOXYCYCLINE HYCLATE
RxCUI 23663
Orange Book
A062475
APAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Doxycycline Hyclate Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "19XTS3T51U",
    "rxcui": "23663",
    "inchikey": "HALQELOKLVRWRI-VDBOFHIQSA-N",
    "display_name": "DOXYCYCLINE HYCLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "9454f948-584f-59de-e053-2a95a90a9f01": {
      "match": "brand_token",
      "title": "DOXY 100(TM) DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]",
      "spl_version": "4",
      "published_date": "2024-02-01"
    }
  },
  "productid": "63323-130_b4654993-19ce-4911-a0d0-4836f357223d",
  "productndc": "63323-130",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "062475",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 100MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Dec 9, 1983"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 200MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Dec 9, 1983"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOXYCYCLINE HYCLATE",
  "shortage_reason": "Doxycycline Hyclate Tablet",
  "shortage_status": "current",
  "proprietary_name": "Doxy 100",
  "active_ingred_unit": "mg/10mL",
  "application_number": "ANDA062475",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DOXYCYCLINE",
  "start_marketing_date": "20001017",
  "active_numerator_strength": "100"
}

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