busPIRone HCl

Orange BookUNIISPLATC N05BE01

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

Identification

ManufacturerAdvagen Pharma Ltd

CountryUS (United States)

ATC codeN05BE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7288806401
100 TABLET in 1 BOTTLE (72888-064-01)
ndc11
7288806405
500 TABLET in 1 BOTTLE (72888-064-05)

Annotations

UNII (FDA Substance ID)

207LT9J9OC

BUSPIRONE HYDROCHLORIDE

RxCUI 203116

Orange Book

A075521

ABABABABAB

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": "72888-064_47c7577d-5093-5361-e063-6294a90ae76f",
  "productndc": "72888-064",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075521",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Apr 5, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Apr 5, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "003",
        "approval_date": "Apr 5, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "004",
        "approval_date": "Mar 16, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "005",
        "approval_date": "Mar 16, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUSPIRONE HYDROCHLORIDE",
  "proprietary_name": "busPIRone HCl",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075521",
  "marketing_category": "ANDA",
  "nonproprietary_name": "buspirone hydrochloride",
  "start_marketing_date": "20201229",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N05BE01.

Access this data programmatically

Query busPIRone HCl and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs