Buspirone Hydrochloride

Orange BookUNIISPLATC N05BE01

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeN05BE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
8280496400
100 TABLET in 1 BOTTLE (82804-964-00)
ndc11
8280496411
1000 TABLET in 1 BOTTLE (82804-964-11)
ndc11
8280496430
30 TABLET in 1 BOTTLE (82804-964-30)
ndc11
8280496455
500 TABLET in 1 BOTTLE (82804-964-55)
ndc11
8280496460
60 TABLET in 1 BOTTLE (82804-964-60)
ndc11
8280496472
120 TABLET in 1 BOTTLE (82804-964-72)
ndc11
8280496490
90 TABLET in 1 BOTTLE (82804-964-90)

Annotations

UNII (FDA Substance ID)

207LT9J9OC

BUSPIRONE HYDROCHLORIDE

RxCUI 203116

Orange Book

A078302

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": "82804-964_1521109d-8386-472f-9483-f1fe9f7ed152",
  "productndc": "82804-964",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078302",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Dec 17, 2007"
      }
    ],
    "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": "ANDA078302",
  "marketing_category": "ANDA",
  "nonproprietary_name": "buspirone hydrochloride",
  "start_marketing_date": "20200501",
  "active_numerator_strength": "30"
}

Related drugs

Other records sharing ATC code N05BE01.

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