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United States · US · US:0527-1395_d237714b-55f8-4a6e-9297-c10d41ab3cd2
Loxapine
Orange BookUNIISPLATC N05AH01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLannett Company, Inc.
CountryUS (United States)
ATC codeN05AH01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc110527139501100 CAPSULE in 1 BOTTLE, PLASTIC (0527-1395-01)
- ndc1105271395101000 CAPSULE in 1 BOTTLE, PLASTIC (0527-1395-10)
Annotations
UNII (FDA Substance ID)
X59SG0MRYU
LOXAPINE SUCCINATE
RxCUI 6476
Orange Book
A090695
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "X59SG0MRYU",
"rxcui": "6476",
"inchikey": "YQZBAXDVDZTKEQ-UHFFFAOYSA-N",
"display_name": "LOXAPINE SUCCINATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"ae8e299c-4003-4ccf-badc-fb665a997b20": {
"match": "brand_token",
"title": "LOXAPINE CAPSULE [REMEDYREPACK INC.]",
"spl_version": "18",
"published_date": "2026-02-19"
}
},
"productid": "0527-1395_d237714b-55f8-4a6e-9297-c10d41ab3cd2",
"productndc": "0527-1395",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "090695",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 5MG BASE",
"product_no": "001",
"approval_date": "Sep 26, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "002",
"approval_date": "Sep 26, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "003",
"approval_date": "Sep 26, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "004",
"approval_date": "Sep 26, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LOXAPINE SUCCINATE",
"proprietary_name": "Loxapine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA090695",
"marketing_category": "ANDA",
"nonproprietary_name": "Loxapine",
"start_marketing_date": "20110926",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N05AH01.
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