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United States · US · US:71335-2516_afe4a662-64fe-49a5-a45c-2bee2070ef85

NEBIVOLOL

In shortageOrange BookUNIISPLATC C07AB12

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC07AB12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7133525161
    30 TABLET in 1 BOTTLE (71335-2516-1)
  • ndc11
    7133525162
    90 TABLET in 1 BOTTLE (71335-2516-2)

Annotations

UNII (FDA Substance ID)
030Y90569U
NEBIVOLOL
RxCUI 31555
Orange Book
A212682
ABABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Nebivolol Hydrochloride Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "030Y90569U",
    "rxcui": "31555",
    "inchikey": "KOHIRBRYDXPAMZ-YHBROIRLSA-N;KOHIRBRYDXPAMZ-YHDSQAASSA-N",
    "display_name": "NEBIVOLOL",
    "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": "71335-2516_afe4a662-64fe-49a5-a45c-2bee2070ef85",
  "productndc": "71335-2516",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "212682",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "Apr 7, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "Apr 7, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "003",
        "approval_date": "Apr 7, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "004",
        "approval_date": "Apr 7, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NEBIVOLOL",
  "shortage_reason": "Nebivolol Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "NEBIVOLOL",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212682",
  "marketing_category": "ANDA",
  "nonproprietary_name": "nebivolol",
  "start_marketing_date": "20220214",
  "active_numerator_strength": "5"
}

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