Bystolic

In shortageOrange BookUNIISPLATC C07AB12

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

Identification

ManufacturerAllergan, Inc.

CountryUS (United States)

ATC codeC07AB12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
0456141001
100 TABLET in 1 BOTTLE (0456-1410-01)
ndc11
0456141030
30 TABLET in 1 BOTTLE (0456-1410-30)
ndc11
0456141063
100 TABLET in 1 BOX, UNIT-DOSE (0456-1410-63)
ndc11
0456141090
90 TABLET in 1 BOTTLE (0456-1410-90)

Annotations

UNII (FDA Substance ID)

JGS34J7L9I

NEBIVOLOL HYDROCHLORIDE

RxCUI 236883

Orange Book

N021742

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": {
    "8b8ad213-1dc8-454e-a524-075685c0e1a8": {
      "match": "brand_token",
      "title": "BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [ALLERGAN, INC.]",
      "spl_version": "31",
      "published_date": "2025-12-31"
    }
  },
  "productid": "0456-1410_0096cdf0-43e6-4128-8990-aed7e1fab83f",
  "productndc": "0456-1410",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021742",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "002",
        "approval_date": "Dec 17, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "003",
        "approval_date": "Dec 17, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "004",
        "approval_date": "Dec 17, 2007"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "005",
        "approval_date": "Oct 8, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NEBIVOLOL HYDROCHLORIDE",
  "shortage_reason": "Nebivolol Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Bystolic",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021742",
  "marketing_category": "NDA",
  "nonproprietary_name": "nebivolol hydrochloride",
  "start_marketing_date": "20080122",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code C07AB12.

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