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United States · US · US:50090-7301_0b07851d-3512-4549-b39b-194211f6946f

NEBIVOLOL

In shortageOrange BookUNIISPLATC C07AB12

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeC07AB12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5009073011
    30 TABLET in 1 BOTTLE (50090-7301-1)
  • ndc11
    5009073012
    90 TABLET in 1 BOTTLE (50090-7301-2)

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": "50090-7301_0b07851d-3512-4549-b39b-194211f6946f",
  "productndc": "50090-7301",
  "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": "20"
}

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