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
6330417303
10 TABLET, FILM COATED in 1 BOTTLE (63304-173-03)
ndc11
6330417310
1000 TABLET, FILM COATED in 1 BOTTLE (63304-173-10)
ndc11
6330417330
30 TABLET, FILM COATED in 1 BOTTLE (63304-173-30)
ndc11
6330417369
1 BLISTER PACK in 1 CARTON (63304-173-69) / 10 TABLET, FILM COATED in 1 BLISTER PACK (63304-173-11)

Annotations

UNII (FDA Substance ID)

N12000U13O

DOXYCYCLINE

RxCUI 203122

Orange Book

A065356

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": "63304-173_fd417a50-69b5-40b4-89fd-58aea77ab547",
  "productndc": "63304-173",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "065356",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "May 31, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "002",
        "approval_date": "May 31, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "May 31, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "004",
        "approval_date": "Jul 29, 2010"
      }
    ],
    "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": "ANDA065356",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxycycline",
  "start_marketing_date": "20180806",
  "active_numerator_strength": "150"
}

Related drugs

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