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United States · US · US:76420-813_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 · 11

  • ndc11
    7642081300
    1000 CAPSULE in 1 BOTTLE (76420-813-00)
  • ndc11
    7642081301
    100 CAPSULE in 1 BOTTLE (76420-813-01)
  • ndc11
    7642081305
    500 CAPSULE in 1 BOTTLE (76420-813-05)
  • ndc11
    7642081310
    10 CAPSULE in 1 BOTTLE (76420-813-10)
  • ndc11
    7642081314
    14 CAPSULE in 1 BOTTLE (76420-813-14)
  • ndc11
    7642081320
    20 CAPSULE in 1 BOTTLE (76420-813-20)
  • ndc11
    7642081328
    28 CAPSULE in 1 BOTTLE (76420-813-28)
  • ndc11
    7642081330
    30 CAPSULE in 1 BOTTLE (76420-813-30)
  • ndc11
    7642081350
    50 CAPSULE in 1 BOTTLE (76420-813-50)
  • ndc11
    7642081360
    60 CAPSULE in 1 BOTTLE (76420-813-60)
  • ndc11
    7642081390
    90 CAPSULE in 1 BOTTLE (76420-813-90)

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": "76420-813_366a864f-98c6-7cf2-e063-6294a90a0268",
  "productndc": "76420-813",
  "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": "100"
}

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