Doxycycline Monohydrate

In shortageOrange BookUNIISPLATC A01AB22

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

Identification

ManufacturerChartwell RX, LLC.

CountryUS (United States)

ATC codeA01AB22

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6213526101
100 CAPSULE in 1 BOTTLE (62135-261-01)

Annotations

UNII (FDA Substance ID)

N12000U13O

DOXYCYCLINE

RxCUI 203122

Orange Book

N050641

ABABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Doxycycline Hyclate Tablet

Raw payload (JSON)

{
  "unii": {
    "unii": "N12000U13O",
    "rxcui": "203122",
    "inchikey": "XQTWDDCIUJNLTR-CVHRZJFOSA-N",
    "display_name": "DOXYCYCLINE",
    "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": "62135-261_3ac1aaae-d186-cf72-e063-6394a90a1dbe",
  "productndc": "62135-261",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "050641",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Dec 29, 1989"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Feb 10, 1992"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "003",
        "approval_date": "Oct 18, 2006"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "004",
        "approval_date": "Feb 17, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOXYCYCLINE",
  "shortage_reason": "Doxycycline Hyclate Tablet",
  "shortage_status": "current",
  "proprietary_name": "Doxycycline Monohydrate",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA050641",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Doxycycline Monohydrate",
  "start_marketing_date": "19891229",
  "active_numerator_strength": "75"
}

Related drugs

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