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United States · US · US:0299-3822_67eef1b6-593a-4277-abd3-f3e60e7557b0
ORACEA
In shortageOrange BookUNIISPLATC A01AB22
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGalderma Laboratories, L.P.
CountryUS (United States)
ATC codeA01AB22
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11029938223030 CAPSULE in 1 BOTTLE (0299-3822-30)
Annotations
UNII (FDA Substance ID)
N12000U13O
DOXYCYCLINE
RxCUI 203122
Orange Book
N050805
AB
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": {
"aa15c93a-ff4c-447a-8a21-96da506d8997": {
"match": "brand_token",
"title": "ORACEA (DOXYCYCLINE) CAPSULE [GALDERMA LABORATORIES, L.P.]",
"spl_version": "23",
"published_date": "2026-02-11"
}
},
"productid": "0299-3822_67eef1b6-593a-4277-abd3-f3e60e7557b0",
"productndc": "0299-3822",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "050805",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "40MG",
"product_no": "001",
"approval_date": "May 26, 2006"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DOXYCYCLINE",
"shortage_reason": "Doxycycline Hyclate Tablet",
"shortage_status": "current",
"proprietary_name": "ORACEA",
"active_ingred_unit": "mg/1",
"application_number": "NDA050805",
"marketing_category": "NDA",
"nonproprietary_name": "DOXYCYCLINE",
"start_marketing_date": "20100514",
"active_numerator_strength": "40"
}Related drugs
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