Buspirone Hydrochloride

Orange BookUNIISPLATC N05BE01

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeN05BE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7161040460
90 TABLET in 1 BOTTLE (71610-404-60)

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": "71610-404_a93360e6-43f6-4652-a7ef-07087a718258",
  "productndc": "71610-404",
  "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": "7.5"
}

Related drugs

Other records sharing ATC code N05BE01.

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