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United States · US · US:72241-035_53d2f49b-b0b8-46fc-b80d-1ac3756e7e7c

Nebivolol

In shortageOrange BookUNIISPLATC C07AB12

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

Identification

ManufacturerModavar Pharmaceuticals LLC
CountryUS (United States)
ATC codeC07AB12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7224103504
    90 TABLET in 1 BOTTLE (72241-035-04)
  • ndc11
    7224103505
    100 TABLET in 1 BOTTLE (72241-035-05)
  • ndc11
    7224103511
    1000 TABLET in 1 BOTTLE (72241-035-11)
  • ndc11
    7224103522
    30 TABLET in 1 BOTTLE (72241-035-22)

Annotations

UNII (FDA Substance ID)
JGS34J7L9I
NEBIVOLOL HYDROCHLORIDE
RxCUI 236883
Orange Book
A208717
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": "72241-035_53d2f49b-b0b8-46fc-b80d-1ac3756e7e7c",
  "productndc": "72241-035",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208717",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "Dec 17, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "Dec 17, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "003",
        "approval_date": "Dec 17, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "004",
        "approval_date": "Dec 17, 2021"
      }
    ],
    "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": "ANDA208717",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nebivolol",
  "start_marketing_date": "20171229",
  "active_numerator_strength": "20"
}

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