Loxapine

Orange BookUNIISPLATC N05AH01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerElite Laboratories, Inc.

CountryUS (United States)

ATC codeN05AH01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6485089001
100 CAPSULE in 1 BOTTLE (64850-890-01)

Annotations

UNII (FDA Substance ID)

X59SG0MRYU

LOXAPINE SUCCINATE

RxCUI 6476

Orange Book

A076868

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": "64850-890_538b7d03-c464-465d-b690-9701c14cf580",
  "productndc": "64850-890",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "076868",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Aug 4, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Aug 4, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "003",
        "approval_date": "Aug 4, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "004",
        "approval_date": "Aug 4, 2005"
      }
    ],
    "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": "ANDA076868",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loxapine",
  "start_marketing_date": "20200127",
  "active_numerator_strength": "5"
}

Related drugs

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