busPIRone HCl

Orange BookUNIISPLATC N05BE01

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeN05BE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
7133597581
30 TABLET in 1 BOTTLE (71335-9758-1)
ndc11
7133597582
60 TABLET in 1 BOTTLE (71335-9758-2)
ndc11
7133597583
90 TABLET in 1 BOTTLE (71335-9758-3)
ndc11
7133597584
45 TABLET in 1 BOTTLE (71335-9758-4)
ndc11
7133597585
180 TABLET in 1 BOTTLE (71335-9758-5)
ndc11
7133597586
120 TABLET in 1 BOTTLE (71335-9758-6)
ndc11
7133597587
10 TABLET in 1 BOTTLE (71335-9758-7)
ndc11
7133597588
100 TABLET in 1 BOTTLE (71335-9758-8)

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": "71335-9758_58de542f-8f84-4d8d-b922-0ca2293f1e66",
  "productndc": "71335-9758",
  "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"
}

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