Buspirone Hydrochloride

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
7133500071
30 TABLET in 1 BOTTLE (71335-0007-1)
ndc11
7133500072
60 TABLET in 1 BOTTLE (71335-0007-2)
ndc11
7133500073
90 TABLET in 1 BOTTLE (71335-0007-3)
ndc11
7133500074
45 TABLET in 1 BOTTLE (71335-0007-4)
ndc11
7133500075
180 TABLET in 1 BOTTLE (71335-0007-5)
ndc11
7133500076
120 TABLET in 1 BOTTLE (71335-0007-6)
ndc11
7133500077
10 TABLET in 1 BOTTLE (71335-0007-7)
ndc11
7133500078
100 TABLET in 1 BOTTLE (71335-0007-8)

Annotations

UNII (FDA Substance ID)

207LT9J9OC

BUSPIRONE HYDROCHLORIDE

RxCUI 203116

Orange Book

A202557

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": "71335-0007_3c65de96-b9f1-4539-8b57-33f9a728dc1e",
  "productndc": "71335-0007",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202557",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Dec 30, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "002",
        "approval_date": "Dec 30, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Dec 30, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "004",
        "approval_date": "Dec 30, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "005",
        "approval_date": "Dec 30, 2014"
      }
    ],
    "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": "ANDA202557",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Buspirone Hydrochloride",
  "start_marketing_date": "20161215",
  "active_numerator_strength": "10"
}

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