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United States · US · US:50090-5761_26df2438-2d17-4683-b43d-68e6605495b3

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
    5009057610
    30 TABLET in 1 BOTTLE (50090-5761-0)
  • ndc11
    5009057612
    90 TABLET in 1 BOTTLE (50090-5761-2)

Annotations

UNII (FDA Substance ID)
JGS34J7L9I
NEBIVOLOL HYDROCHLORIDE
RxCUI 236883
Orange Book
A203828
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": "50090-5761_26df2438-2d17-4683-b43d-68e6605495b3",
  "productndc": "50090-5761",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "203828",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "Jul 29, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "Jul 29, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "003",
        "approval_date": "Jul 29, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "004",
        "approval_date": "Jul 29, 2015"
      }
    ],
    "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": "ANDA203828",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nebivolol",
  "start_marketing_date": "20210916",
  "active_numerator_strength": "10"
}

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