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United States · US · US:72578-054_ebe90bc1-d956-4813-9d89-16212c08966b

Doxycycline hyclate

In shortageOrange BookUNIISPLATC A01AB

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

Identification

ManufacturerViona Pharmaceuticals Inc
CountryUS (United States)
ATC codeA01AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    7257805401
    100 CAPSULE in 1 BOTTLE (72578-054-01)
  • ndc11
    7257805405
    500 CAPSULE in 1 BOTTLE (72578-054-05)
  • ndc11
    7257805410
    1000 CAPSULE in 1 BOTTLE (72578-054-10)
  • ndc11
    7257805418
    50 CAPSULE in 1 BOTTLE (72578-054-18)
  • ndc11
    7257805477
    10 BLISTER PACK in 1 CARTON (72578-054-77) / 10 CAPSULE in 1 BLISTER PACK (72578-054-30)

Annotations

UNII (FDA Substance ID)
19XTS3T51U
DOXYCYCLINE HYCLATE
RxCUI 23663
Orange Book
A207774
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": "72578-054_ebe90bc1-d956-4813-9d89-16212c08966b",
  "productndc": "72578-054",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "207774",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "May 31, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "002",
        "approval_date": "May 31, 2018"
      }
    ],
    "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": "ANDA207774",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxycycline hyclate",
  "start_marketing_date": "20220110",
  "active_numerator_strength": "50"
}

Related drugs

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