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 · 2

ndc11
4280608201
100 TABLET in 1 BOTTLE (42806-082-01)
ndc11
4280608205
500 TABLET in 1 BOTTLE (42806-082-05)

Annotations

UNII (FDA Substance ID)

207LT9J9OC

BUSPIRONE HYDROCHLORIDE

RxCUI 203116

Orange Book

A208972

BXBXBXBXBX

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "207LT9J9OC",
    "rxcui": "203116",
    "inchikey": "RICLFGYGYQXUFH-UHFFFAOYSA-N",
    "display_name": "BUSPIRONE HYDROCHLORIDE",
    "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": "42806-082_02628a0c-bfdb-4a58-8e48-bcd8ca12d53b",
  "productndc": "42806-082",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208972",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Apr 16, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "7.5MG",
        "product_no": "002",
        "approval_date": "Apr 16, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Apr 16, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "15MG",
        "product_no": "004",
        "approval_date": "Apr 16, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "30MG",
        "product_no": "005",
        "approval_date": "Apr 16, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUSPIRONE HYDROCHLORIDE",
  "proprietary_name": "Buspirone Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208972",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Buspirone Hydrochloride",
  "start_marketing_date": "20190417",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N05BE01.

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