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United States · US · US:46708-353_8a6d5c0f-9b8e-444e-882e-8a2264410c02

Doxycycline Hyclate

In shortageOrange BookUNIISPLATC A01AB

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

Identification

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

Packs · 3

  • ndc11
    4670835320
    20 TABLET, FILM COATED in 1 BOTTLE (46708-353-20)
  • ndc11
    4670835350
    50 TABLET, FILM COATED in 1 BOTTLE (46708-353-50)
  • ndc11
    4670835371
    500 TABLET, FILM COATED in 1 BOTTLE (46708-353-71)

Annotations

UNII (FDA Substance ID)
19XTS3T51U
DOXYCYCLINE HYCLATE
RxCUI 23663
Orange Book
A210536
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": "46708-353_8a6d5c0f-9b8e-444e-882e-8a2264410c02",
  "productndc": "46708-353",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "210536",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "May 14, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Sep 14, 2021"
      }
    ],
    "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": "ANDA210536",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxycycline Hyclate",
  "start_marketing_date": "20200515",
  "active_numerator_strength": "100"
}

Related drugs

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