Doxycycline

In shortageOrange BookUNIISPLATC A01AB22

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeA01AB22

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
8280405002
2 CAPSULE in 1 BOTTLE (82804-050-02)
ndc11
8280405006
6 CAPSULE in 1 BOTTLE (82804-050-06)
ndc11
8280405010
10 CAPSULE in 1 BOTTLE (82804-050-10)
ndc11
8280405014
14 CAPSULE in 1 BOTTLE (82804-050-14)
ndc11
8280405020
20 CAPSULE in 1 BOTTLE (82804-050-20)
ndc11
8280405030
30 CAPSULE in 1 BOTTLE (82804-050-30)
ndc11
8280405060
60 CAPSULE in 1 BOTTLE (82804-050-60)
ndc11
8280405090
90 CAPSULE in 1 BOTTLE (82804-050-90)

Annotations

UNII (FDA Substance ID)

N12000U13O

DOXYCYCLINE

RxCUI 203122

Orange Book

A065055

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": "82804-050_c707566b-dbc7-4dac-bad1-952f2f4d6845",
  "productndc": "82804-050",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "065055",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Dec 1, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "002",
        "approval_date": "Dec 1, 2000"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "003",
        "approval_date": "Jul 15, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 75MG BASE",
        "product_no": "004",
        "approval_date": "Apr 18, 2005"
      }
    ],
    "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": "ANDA065055",
  "marketing_category": "ANDA",
  "nonproprietary_name": "doxycycline",
  "start_marketing_date": "20220801",
  "active_numerator_strength": "100"
}

Related drugs

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