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United States · US · US:68382-782_9486a93f-bc2a-444a-a8d4-3bce410d21c7

doxycycline

In shortageOrange BookUNIISPLATC A01AB22

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeA01AB22
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    6838278201
    100 CAPSULE in 1 BOTTLE (68382-782-01)
  • ndc11
    6838278205
    500 CAPSULE in 1 BOTTLE (68382-782-05)
  • ndc11
    6838278206
    30 CAPSULE in 1 BOTTLE (68382-782-06)
  • ndc11
    6838278210
    1000 CAPSULE in 1 BOTTLE (68382-782-10)
  • ndc11
    6838278216
    90 CAPSULE in 1 BOTTLE (68382-782-16)
  • ndc11
    6838278218
    50 CAPSULE in 1 BOTTLE (68382-782-18)
  • ndc11
    6838278277
    10 BLISTER PACK in 1 CARTON (68382-782-77) / 10 CAPSULE in 1 BLISTER PACK (68382-782-30)

Annotations

UNII (FDA Substance ID)
N12000U13O
DOXYCYCLINE
RxCUI 203122
Orange Book
A205115
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": "68382-782_9486a93f-bc2a-444a-a8d4-3bce410d21c7",
  "productndc": "68382-782",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "205115",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Feb 18, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "002",
        "approval_date": "Feb 18, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "Feb 18, 2016"
      }
    ],
    "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": "ANDA205115",
  "marketing_category": "ANDA",
  "nonproprietary_name": "doxycycline",
  "start_marketing_date": "20160314",
  "active_numerator_strength": "50"
}

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