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United States · US · US:76420-814_366a864f-98c6-7cf2-e063-6294a90a0268

Doxycycline hyclate

In shortageOrange BookUNIISPLATC A01AB

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

Identification

ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeA01AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 10

  • ndc11
    7642081400
    1000 CAPSULE in 1 BOTTLE (76420-814-00)
  • ndc11
    7642081401
    100 CAPSULE in 1 BOTTLE (76420-814-01)
  • ndc11
    7642081405
    500 CAPSULE in 1 BOTTLE (76420-814-05)
  • ndc11
    7642081410
    10 CAPSULE in 1 BOTTLE (76420-814-10)
  • ndc11
    7642081414
    14 CAPSULE in 1 BOTTLE (76420-814-14)
  • ndc11
    7642081420
    20 CAPSULE in 1 BOTTLE (76420-814-20)
  • ndc11
    7642081430
    30 CAPSULE in 1 BOTTLE (76420-814-30)
  • ndc11
    7642081450
    50 CAPSULE in 1 BOTTLE (76420-814-50)
  • ndc11
    7642081460
    60 CAPSULE in 1 BOTTLE (76420-814-60)
  • ndc11
    7642081490
    90 CAPSULE in 1 BOTTLE (76420-814-90)

Annotations

UNII (FDA Substance ID)
19XTS3T51U
DOXYCYCLINE HYCLATE
RxCUI 23663
Orange Book
A207774
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Doxycycline Hyclate Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "19XTS3T51U",
    "rxcui": "23663",
    "inchikey": "HALQELOKLVRWRI-VDBOFHIQSA-N",
    "display_name": "DOXYCYCLINE HYCLATE",
    "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": "76420-814_366a864f-98c6-7cf2-e063-6294a90a0268",
  "productndc": "76420-814",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "207774",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "May 31, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "002",
        "approval_date": "May 31, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOXYCYCLINE HYCLATE",
  "shortage_reason": "Doxycycline Hyclate Tablet",
  "shortage_status": "current",
  "proprietary_name": "Doxycycline hyclate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207774",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxycycline hyclate",
  "start_marketing_date": "20220110",
  "active_numerator_strength": "50"
}

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