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United States · US · US:0527-1397_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

  • ndc11
    0527139701
    100 CAPSULE in 1 BOTTLE, PLASTIC (0527-1397-01)
  • ndc11
    0527139710
    1000 CAPSULE in 1 BOTTLE, PLASTIC (0527-1397-10)

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": "0527-1397_d237714b-55f8-4a6e-9297-c10d41ab3cd2",
  "productndc": "0527-1397",
  "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": "50"
}

Related drugs

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