Doxycycline Hyclate

In shortageOrange BookUNIISPLATC A01AB

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

Identification

ManufacturerChartwell RX LLC

CountryUS (United States)

ATC codeA01AB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 11

ndc11
6213562601
100 TABLET, FILM COATED in 1 BOTTLE (62135-626-01)
ndc11
6213562605
500 TABLET, FILM COATED in 1 BOTTLE (62135-626-05)
ndc11
6213562610
1000 TABLET, FILM COATED in 1 BOTTLE (62135-626-10)
ndc11
6213562612
120 TABLET, FILM COATED in 1 BOTTLE (62135-626-12)
ndc11
6213562620
20 TABLET, FILM COATED in 1 BOTTLE (62135-626-20)
ndc11
6213562623
210 TABLET, FILM COATED in 1 BOTTLE (62135-626-23)
ndc11
6213562628
28 TABLET, FILM COATED in 1 BOTTLE (62135-626-28)
ndc11
6213562631
300 TABLET, FILM COATED in 1 BOTTLE (62135-626-31)
ndc11
6213562640
400 TABLET, FILM COATED in 1 BOTTLE (62135-626-40)
ndc11
6213562650
50 TABLET, FILM COATED in 1 BOTTLE (62135-626-50)
ndc11
6213562696
2000 TABLET, FILM COATED in 1 BOTTLE (62135-626-96)

Annotations

UNII (FDA Substance ID)

19XTS3T51U

DOXYCYCLINE HYCLATE

RxCUI 23663

Orange Book

A062505

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": "62135-626_40077986-5ebb-f8f0-e063-6394a90ad09f",
  "productndc": "62135-626",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "062505",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Sep 11, 1984"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Jul 27, 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": "ANDA062505",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxycycline Hyclate",
  "start_marketing_date": "19840911",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code A01AB.

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