Buspirone hydrochloride

Orange BookUNIISPLATC N05BE01

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeN05BE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7051803800
30 TABLET in 1 BLISTER PACK (70518-0380-0)

Annotations

UNII (FDA Substance ID)

207LT9J9OC

BUSPIRONE HYDROCHLORIDE

RxCUI 203116

Orange Book

A078888

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": "70518-0380_2b4cb86d-e507-3651-e063-6394a90a8848",
  "productndc": "70518-0380",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078888",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Feb 7, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Feb 7, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "003",
        "approval_date": "Feb 7, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "004",
        "approval_date": "Feb 7, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "005",
        "approval_date": "Mar 21, 2023"
      }
    ],
    "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": "ANDA078888",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Buspirone hydrochloride",
  "start_marketing_date": "20170403",
  "active_numerator_strength": "15"
}

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