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United States · US · US:42806-310_108c5769-3b01-40dd-b493-1f38df313b4c

Doxycycline Hyclate

In shortageOrange BookUNIISPLATC A01AB

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

Identification

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

Packs · 3

  • ndc11
    4280631001
    100 TABLET, FILM COATED in 1 BOTTLE (42806-310-01)
  • ndc11
    4280631005
    500 TABLET, FILM COATED in 1 BOTTLE (42806-310-05)
  • ndc11
    4280631050
    50 TABLET, FILM COATED in 1 BOTTLE (42806-310-50)

Annotations

UNII (FDA Substance ID)
19XTS3T51U
DOXYCYCLINE HYCLATE
RxCUI 23663
Orange Book
A062269
ABAB
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": "ORAL",
  "spl_meta": {
    "52ba329a-8cb3-cf30-e063-6394a90aa0dc": {
      "match": "brand_token",
      "title": "DOXYCYCLINE HYCLATE CAPSULE [COUPLER LLC]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "42806-310_108c5769-3b01-40dd-b493-1f38df313b4c",
  "productndc": "42806-310",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "062269",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "002",
        "approval_date": "Nov 8, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "003",
        "approval_date": "Oct 5, 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": "Doxycycline Hyclate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA062269",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxycycline Hyclate",
  "start_marketing_date": "20250307",
  "active_numerator_strength": "100"
}

Related drugs

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