DOXYCYCLINE HYCLATE

In shortageOrange BookUNIISPLATC A01AB

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAlembic Pharmaceuticals Limited

CountryUS (United States)

ATC codeA01AB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4670838860
60 TABLET, FILM COATED in 1 BOTTLE (46708-388-60)
ndc11
4670838891
1000 TABLET, FILM COATED in 1 BOTTLE (46708-388-91)

Annotations

UNII (FDA Substance ID)

19XTS3T51U

DOXYCYCLINE HYCLATE

RxCUI 23663

Orange Book

A211744

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": "46708-388_8becf01f-63de-4cf3-881e-94d18fe9274c",
  "productndc": "46708-388",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "211744",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "001",
        "approval_date": "Jun 30, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "002",
        "approval_date": "Jun 30, 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 HYCLATE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211744",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DOXYCYCLINE HYCLATE",
  "start_marketing_date": "20200630",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code A01AB.

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