BUSPIRONE HYDROCHLORIDE

Orange BookUNIISPLATC N05BE01

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeN05BE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
5965138901
100 TABLET in 1 BOTTLE (59651-389-01)
ndc11
5965138905
500 TABLET in 1 BOTTLE (59651-389-05)
ndc11
5965138910
10 BLISTER PACK in 1 CARTON (59651-389-10) / 10 TABLET in 1 BLISTER PACK
ndc11
5965138930
30 TABLET in 1 BOTTLE (59651-389-30)
ndc11
5965138960
60 TABLET in 1 BOTTLE (59651-389-60)

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": "59651-389_270d4008-311a-4f5c-905e-95f14bd9f700",
  "productndc": "59651-389",
  "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": "5"
}

Related drugs

Other records sharing ATC code N05BE01.

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