Nebivolol

In shortageOrange BookUNIISPLATC C07AB12

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

Identification

ManufacturerAscend Laboratories, LLC

CountryUS (United States)

ATC codeC07AB12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6787739201
100 TABLET in 1 BOTTLE (67877-392-01)
ndc11
6787739230
30 TABLET in 1 BOTTLE (67877-392-30)
ndc11
6787739233
1 BLISTER PACK in 1 CARTON (67877-392-33) / 10 TABLET in 1 BLISTER PACK
ndc11
6787739290
90 TABLET in 1 BOTTLE (67877-392-90)

Annotations

UNII (FDA Substance ID)

JGS34J7L9I

NEBIVOLOL HYDROCHLORIDE

RxCUI 236883

Orange Book

A203828

ABABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Nebivolol Hydrochloride Tablet

Raw payload (JSON)

{
  "unii": {
    "unii": "JGS34J7L9I",
    "rxcui": "236883",
    "inchikey": "JWEXHQAEWHKGCW-VCVZPGOSSA-N;JWEXHQAEWHKGCW-BIISKSHESA-N",
    "display_name": "NEBIVOLOL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3e9e1048-b5ea-4d6a-9363-3ee0d059e088": {
      "match": "brand_token",
      "title": "NEBIVOLOL TABLET [MAJOR PHARMACEUTICALS]",
      "spl_version": "4",
      "published_date": "2026-05-21"
    }
  },
  "productid": "67877-392_4f315a54-2598-4463-8884-0b643e86f8c0",
  "productndc": "67877-392",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "203828",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "Jul 29, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "Jul 29, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "003",
        "approval_date": "Jul 29, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "004",
        "approval_date": "Jul 29, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NEBIVOLOL HYDROCHLORIDE",
  "shortage_reason": "Nebivolol Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Nebivolol",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203828",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nebivolol",
  "start_marketing_date": "20210916",
  "active_numerator_strength": "5"
}

Related drugs

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