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United States · US · US:68788-8588_43c87c27-049c-4cb8-99c3-1d14e16eea95

doxycycline

In shortageOrange BookUNIISPLATC A01AB

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

Identification

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

Packs · 5

  • ndc11
    6878885881
    14 CAPSULE in 1 BOTTLE (68788-8588-1)
  • ndc11
    6878885882
    20 CAPSULE in 1 BOTTLE (68788-8588-2)
  • ndc11
    6878885883
    30 CAPSULE in 1 BOTTLE (68788-8588-3)
  • ndc11
    6878885886
    60 CAPSULE in 1 BOTTLE (68788-8588-6)
  • ndc11
    6878885888
    28 CAPSULE in 1 BOTTLE (68788-8588-8)

Annotations

UNII (FDA Substance ID)
19XTS3T51U
DOXYCYCLINE HYCLATE
RxCUI 23663
Orange Book
A209402
AB
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": "68788-8588_43c87c27-049c-4cb8-99c3-1d14e16eea95",
  "productndc": "68788-8588",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "209402",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Oct 7, 2019"
      }
    ],
    "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",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209402",
  "marketing_category": "ANDA",
  "nonproprietary_name": "doxycycline",
  "start_marketing_date": "20240220",
  "active_numerator_strength": "100"
}

Related drugs

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