nebivolol

In shortageOrange BookUNIISPLATC C07AB12

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA

CountryUS (United States)

ATC codeC07AB12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6846261801
100 TABLET in 1 BOTTLE (68462-618-01)
ndc11
6846261811
10 BLISTER PACK in 1 CARTON (68462-618-11) / 10 TABLET in 1 BLISTER PACK
ndc11
6846261830
30 TABLET in 1 BOTTLE (68462-618-30)

Annotations

UNII (FDA Substance ID)

JGS34J7L9I

NEBIVOLOL HYDROCHLORIDE

RxCUI 236883

Orange Book

A203821

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": "68462-618_151f00ae-13ed-4174-bf4d-bc30f1fb9d69",
  "productndc": "68462-618",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "203821",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "May 25, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "May 25, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "003",
        "approval_date": "May 25, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "004",
        "approval_date": "May 25, 2017"
      }
    ],
    "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": "ANDA203821",
  "marketing_category": "ANDA",
  "nonproprietary_name": "nebivolol hydrochloride",
  "start_marketing_date": "20170525",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code C07AB12.

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