Buspirone hydrochloride

Orange BookUNIISPLATC N05BE01

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeN05BE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6838218201
100 TABLET in 1 BOTTLE (68382-182-01)
ndc11
6838218205
500 TABLET in 1 BOTTLE (68382-182-05)
ndc11
6838218210
1000 TABLET in 1 BOTTLE (68382-182-10)
ndc11
6838218214
60 TABLET in 1 BOTTLE (68382-182-14)
ndc11
6838218228
180 TABLET in 1 BOTTLE (68382-182-28)
ndc11
6838218277
100 BLISTER PACK in 1 CARTON (68382-182-77) / 1 TABLET in 1 BLISTER PACK (68382-182-30)

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": "68382-182_8692aee8-7eb4-4cbb-8a31-3ecc49660195",
  "productndc": "68382-182",
  "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": "20140503",
  "active_numerator_strength": "15"
}

Related drugs

Other records sharing ATC code N05BE01.

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