Doxycycline

In shortageOrange BookUNIISPLATC A01AB22

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeA01AB22

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6330461401
100 CAPSULE in 1 BOTTLE (63304-614-01)
ndc11
6330461405
500 CAPSULE in 1 BOTTLE (63304-614-05)
ndc11
6330461413
120 CAPSULE in 1 BOTTLE (63304-614-13)
ndc11
6330461420
20 CAPSULE in 1 BOTTLE (63304-614-20)

Annotations

UNII (FDA Substance ID)

N12000U13O

DOXYCYCLINE

RxCUI 203122

Orange Book

A065053

ABABAB

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": "63304-614_338488d1-e9d8-6b00-e063-6294a90a37c0",
  "productndc": "63304-614",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "065053",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Nov 22, 2000"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "002",
        "approval_date": "Nov 22, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "003",
        "approval_date": "Sep 10, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOXYCYCLINE",
  "shortage_reason": "Doxycycline Hyclate Tablet",
  "shortage_status": "current",
  "proprietary_name": "Doxycycline",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065053",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxycycline",
  "start_marketing_date": "20001226",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code A01AB22.

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