NEBIVOLOL

In shortageOrange BookUNIISPLATC C07AB12

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeC07AB12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7051846480
50 POUCH in 1 BOX (70518-4648-0) / 1 TABLET in 1 POUCH (70518-4648-1)

Annotations

UNII (FDA Substance ID)

JGS34J7L9I

NEBIVOLOL HYDROCHLORIDE

RxCUI 236883

Orange Book

A217397

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": "70518-4648_509898af-5f31-b49c-e063-6394a90a4b82",
  "productndc": "70518-4648",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "217397",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "Oct 1, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "Oct 1, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "003",
        "approval_date": "Oct 1, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "004",
        "approval_date": "Oct 1, 2024"
      }
    ],
    "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": "ANDA217397",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NEBIVOLOL",
  "start_marketing_date": "20260428",
  "active_numerator_strength": "5"
}

Related drugs

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