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United States · US · US:42192-501_3b12eb84-4431-551b-e063-6294a90acd6c

Doxycycline

In shortageOrange BookUNIISPLATC A01AB

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

Identification

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

Packs · 2

  • ndc11
    4219250105
    500 TABLET, COATED in 1 BOTTLE (42192-501-05)
  • ndc11
    4219250150
    50 TABLET, COATED in 1 BOTTLE (42192-501-50)

Annotations

UNII (FDA Substance ID)
19XTS3T51U
DOXYCYCLINE HYCLATE
RxCUI 23663
Orange Book
A210664
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": "42192-501_3b12eb84-4431-551b-e063-6294a90acd6c",
  "productndc": "42192-501",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "210664",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Mar 16, 2020"
      }
    ],
    "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": "ANDA210664",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxycycline hyclate",
  "start_marketing_date": "20200821",
  "active_numerator_strength": "100"
}

Related drugs

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