Nebivolol

In shortageOrange BookUNIISPLATC C07AB12

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

Identification

ManufacturerCamber Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeC07AB12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
3172258501
100 TABLET in 1 BOTTLE (31722-585-01)
ndc11
3172258530
30 TABLET in 1 BOTTLE (31722-585-30)
ndc11
3172258532
12 BLISTER PACK in 1 CARTON (31722-585-32) / 10 TABLET in 1 BLISTER PACK (31722-585-31)
ndc11
3172258534
15 BLISTER PACK in 1 CARTON (31722-585-34) / 10 TABLET in 1 BLISTER PACK (31722-585-33)

Annotations

UNII (FDA Substance ID)

JGS34J7L9I

NEBIVOLOL HYDROCHLORIDE

RxCUI 236883

Orange Book

A203825

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": "31722-585_103af555-44dd-5dfb-e063-6294a90a259f",
  "productndc": "31722-585",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "203825",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "Nov 3, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "Nov 3, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "003",
        "approval_date": "Nov 3, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "004",
        "approval_date": "Nov 3, 2020"
      }
    ],
    "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": "ANDA203825",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nebivolol",
  "start_marketing_date": "20210917",
  "active_numerator_strength": "2.5"
}

Related drugs

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