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 · 6

ndc11
7133521931
30 TABLET in 1 BOTTLE (71335-2193-1)
ndc11
7133521932
90 TABLET in 1 BOTTLE (71335-2193-2)
ndc11
7133521933
18 TABLET in 1 BOTTLE (71335-2193-3)
ndc11
7133521934
28 TABLET in 1 BOTTLE (71335-2193-4)
ndc11
7133521935
60 TABLET in 1 BOTTLE (71335-2193-5)
ndc11
7133521936
120 TABLET in 1 BOTTLE (71335-2193-6)

Annotations

UNII (FDA Substance ID)

207LT9J9OC

BUSPIRONE HYDROCHLORIDE

RxCUI 203116

Orange Book

A078246

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": "71335-2193_341c39a0-db88-425c-a85d-238e87945e72",
  "productndc": "71335-2193",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078246",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Feb 27, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Feb 27, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "003",
        "approval_date": "Feb 27, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "004",
        "approval_date": "Feb 27, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "005",
        "approval_date": "Feb 21, 2020"
      }
    ],
    "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": "ANDA078246",
  "marketing_category": "ANDA",
  "nonproprietary_name": "BUSPIRONE HYDROCHLORIDE",
  "start_marketing_date": "20200221",
  "active_numerator_strength": "7.5"
}

Related drugs

Other records sharing ATC code N05BE01.

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