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
7133596731
30 TABLET in 1 BOTTLE (71335-9673-1)
ndc11
7133596732
60 TABLET in 1 BOTTLE (71335-9673-2)
ndc11
7133596733
90 TABLET in 1 BOTTLE (71335-9673-3)
ndc11
7133596734
45 TABLET in 1 BOTTLE (71335-9673-4)
ndc11
7133596735
180 TABLET in 1 BOTTLE (71335-9673-5)
ndc11
7133596736
120 TABLET in 1 BOTTLE (71335-9673-6)
ndc11
7133596737
10 TABLET in 1 BOTTLE (71335-9673-7)
ndc11
7133596738
100 TABLET in 1 BOTTLE (71335-9673-8)

Annotations

UNII (FDA Substance ID)

207LT9J9OC

BUSPIRONE HYDROCHLORIDE

RxCUI 203116

Orange Book

A075388

ABABAB

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": "71335-9673_981f7fec-deaa-470e-aa7d-4aca03db528a",
  "productndc": "71335-9673",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075388",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "May 9, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "May 9, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "003",
        "approval_date": "May 9, 2002"
      }
    ],
    "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": "ANDA075388",
  "marketing_category": "ANDA",
  "nonproprietary_name": "buspirone hydrochloride",
  "start_marketing_date": "20200727",
  "active_numerator_strength": "10"
}

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