🇺🇸
United States · US · US:63304-616_338488d1-e9d8-6b00-e063-6294a90a37c0
Doxycycline
In shortageOrange BookUNIISPLATC A01AB22
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeA01AB22
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116330461601100 CAPSULE in 1 BOTTLE (63304-616-01)
- ndc116330461605500 CAPSULE in 1 BOTTLE (63304-616-05)
- ndc116330461613120 CAPSULE in 1 BOTTLE (63304-616-13)
- ndc11633046162020 CAPSULE in 1 BOTTLE (63304-616-20)
- ndc11633046165050 CAPSULE in 1 BOTTLE (63304-616-50)
Annotations
UNII (FDA Substance ID)
N12000U13O
DOXYCYCLINE
RxCUI 203122
Orange Book
A065053
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": "63304-616_338488d1-e9d8-6b00-e063-6294a90a37c0",
"productndc": "63304-616",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "065053",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "001",
"approval_date": "Nov 22, 2000"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "002",
"approval_date": "Nov 22, 2000"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 75MG BASE",
"product_no": "003",
"approval_date": "Sep 10, 2003"
}
],
"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": "ANDA065053",
"marketing_category": "ANDA",
"nonproprietary_name": "Doxycycline",
"start_marketing_date": "20001226",
"active_numerator_strength": "100"
}Related drugs
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