Doxycycline

In shortageOrange BookUNIISPLATC A01AB

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeA01AB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 21

ndc11
5528986601
100 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-01)
ndc11
5528986602
2 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-02)
ndc11
5528986604
4 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-04)
ndc11
5528986606
6 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-06)
ndc11
5528986607
7 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-07)
ndc11
5528986610
10 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-10)
ndc11
5528986620
20 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-20)
ndc11
5528986628
28 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-28)
ndc11
5528986630
30 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-30)
ndc11
5528986650
50 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-50)
ndc11
5528986660
60 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-60)
ndc11
5528986671
210 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-71)
ndc11
5528986674
400 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-74)
ndc11
5528986682
500 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-82)
ndc11
5528986685
330 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-85)
ndc11
5528986686
360 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-86)
ndc11
5528986687
300 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-87)
ndc11
5528986690
90 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-90)
ndc11
5528986693
180 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-93)
ndc11
5528986695
1000 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-95)
ndc11
5528986698
120 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-98)

Annotations

UNII (FDA Substance ID)

19XTS3T51U

DOXYCYCLINE HYCLATE

RxCUI 23663

Orange Book

A065095

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": "55289-866_4d536efb-27b1-2589-e063-6394a90ad3e4",
  "productndc": "55289-866",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "065095",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Jul 2, 2003"
      }
    ],
    "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": "ANDA065095",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxycycline Hyclate",
  "start_marketing_date": "20030702",
  "active_numerator_strength": "100"
}

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