Doxycycline Hyclate

In shortageOrange BookUNIISPLATC A01AB

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeA01AB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
5348964701
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-01)
ndc11
5348964703
250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-03)
ndc11
5348964705
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-05)
ndc11
5348964706
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-06)
ndc11
5348964707
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-07)
ndc11
5348964710
1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-10)
ndc11
5348964790
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-90)

Annotations

UNII (FDA Substance ID)

19XTS3T51U

DOXYCYCLINE HYCLATE

RxCUI 23663

Orange Book

A065134

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": "53489-647_31dd6775-5a9a-9e21-e063-6294a90aa546",
  "productndc": "53489-647",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "065134",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "May 13, 2005"
      }
    ],
    "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": "ANDA065134",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxycycline Hyclate",
  "start_marketing_date": "20050513",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code A01AB.

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