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United States · US · US:72888-065_47c7577d-5093-5361-e063-6294a90ae76f

busPIRone HCl

Orange BookUNIISPLATC N05BE01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAdvagen Pharma Ltd
CountryUS (United States)
ATC codeN05BE01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7288806501
    100 TABLET in 1 BOTTLE (72888-065-01)
  • ndc11
    7288806505
    500 TABLET in 1 BOTTLE (72888-065-05)
  • ndc11
    7288806560
    60 TABLET in 1 BOTTLE (72888-065-60)

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": "72888-065_47c7577d-5093-5361-e063-6294a90ae76f",
  "productndc": "72888-065",
  "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": "15"
}

Related drugs

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