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United States · US · US:53746-555_bd37276e-8e9f-48ec-9565-a83a5a4f9aea
Demeclocycline Hydrochloride
Orange BookUNIISPLATC D06AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeD06AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11537465554848 TABLET in 1 BOTTLE (53746-555-48)
Annotations
UNII (FDA Substance ID)
29O079NTYT
DEMECLOCYCLINE HYDROCHLORIDE
RxCUI 81993
Orange Book
A065425
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "29O079NTYT",
"rxcui": "81993",
"inchikey": "GVSJQNRGSCOSNJ-KBHRXELFSA-N",
"display_name": "DEMECLOCYCLINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"88e03cb0-25f5-41a5-b77f-58ab8f3be181": {
"match": "brand_token",
"title": "DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [PURACAP LABORATORIES LLC]",
"spl_version": "6",
"published_date": "2025-12-12"
}
},
"productid": "53746-555_bd37276e-8e9f-48ec-9565-a83a5a4f9aea",
"productndc": "53746-555",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "065425",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "001",
"approval_date": "Feb 27, 2008"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "Feb 27, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEMECLOCYCLINE HYDROCHLORIDE",
"proprietary_name": "Demeclocycline Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA065425",
"marketing_category": "ANDA",
"nonproprietary_name": "Demeclocycline",
"start_marketing_date": "20220525",
"active_numerator_strength": "300"
}Related drugs
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