Buspirone Hydrochloride

Orange BookUNIISPLATC N05BE01

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

Identification

ManufacturerEPIC PHARMA, LLC

CountryUS (United States)

ATC codeN05BE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4280683201
100 CAPSULE in 1 BOTTLE (42806-832-01)

Annotations

UNII (FDA Substance ID)

TK65WKS8HL

BUSPIRONE

RxCUI 1827

Orange Book

A218628

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "TK65WKS8HL",
    "rxcui": "1827",
    "inchikey": "QWCRAEMEVRGPNT-UHFFFAOYSA-N",
    "display_name": "BUSPIRONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2c516eec-65d9-4481-8823-ae6b6da84062": {
      "match": "brand_token",
      "title": "BUSPIRONE HYDROCHLORIDE TABLET [IPG PHARMACEUTICALS, INC]",
      "spl_version": "2",
      "published_date": "2026-06-02"
    }
  },
  "productid": "42806-832_160f52d2-2e08-4969-80c3-c653767652f0",
  "productndc": "42806-832",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "218628",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "7.5MG",
        "product_no": "001",
        "approval_date": "Mar 13, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Mar 13, 2025"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "15MG",
        "product_no": "003",
        "approval_date": "Mar 13, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "004",
        "approval_date": "Apr 29, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUSPIRONE",
  "proprietary_name": "Buspirone Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA218628",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Buspirone Hydrochloride",
  "start_marketing_date": "20250313",
  "active_numerator_strength": "10"
}

Related drugs

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