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United States · US · US:43547-324_49c9be01-a1bf-48aa-8ef4-0584e8dcaac5

DOXYCYCLINE HYCLATE

In shortageOrange BookUNIISPLATC A01AB

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

Identification

ManufacturerSolco Healthcare US LLC
CountryUS (United States)
ATC codeA01AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4354732406
    60 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-324-06)
  • ndc11
    4354732410
    100 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-324-10)
  • ndc11
    4354732450
    500 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-324-50)

Annotations

UNII (FDA Substance ID)
19XTS3T51U
DOXYCYCLINE HYCLATE
RxCUI 23663
Orange Book
A207494
ABABAB
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": "43547-324_49c9be01-a1bf-48aa-8ef4-0584e8dcaac5",
  "productndc": "43547-324",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "207494",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "001",
        "approval_date": "Nov 15, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "002",
        "approval_date": "Nov 15, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "003",
        "approval_date": "Feb 19, 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 HYCLATE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207494",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DOXYCYCLINE HYCLATE",
  "start_marketing_date": "20161128",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code A01AB.

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