bumetanide

In shortageOrange BookUNIISPLATC C03CA02

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

Identification

ManufacturerZydus Pharmaceuticals (USA) Inc.

CountryUS (United States)

ATC codeC03CA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6838252701
100 TABLET in 1 BOTTLE (68382-527-01)
ndc11
6838252705
500 TABLET in 1 BOTTLE (68382-527-05)
ndc11
6838252706
30 TABLET in 1 BOTTLE (68382-527-06)
ndc11
6838252710
1000 TABLET in 1 BOTTLE (68382-527-10)
ndc11
6838252716
90 TABLET in 1 BOTTLE (68382-527-16)

Annotations

UNII (FDA Substance ID)

0Y2S3XUQ5H

BUMETANIDE

RxCUI 1808

Orange Book

A202900

ABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Bumetanide Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "0Y2S3XUQ5H",
    "rxcui": "1808",
    "inchikey": "MAEIEVLCKWDQJH-UHFFFAOYSA-N",
    "display_name": "BUMETANIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "551918e1-96c4-453a-870c-61b282882206": {
      "match": "brand_token",
      "title": "BUMETANIDE TABLET [NORTHSTAR RX LLC]",
      "spl_version": "1",
      "published_date": "2026-06-02"
    }
  },
  "productid": "68382-527_58b3bb3b-6096-42fd-aebc-c856c3050071",
  "productndc": "68382-527",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202900",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Apr 30, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Apr 30, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Apr 30, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUMETANIDE",
  "shortage_reason": "Bumetanide Injection",
  "shortage_status": "current",
  "proprietary_name": "bumetanide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202900",
  "marketing_category": "ANDA",
  "nonproprietary_name": "bumetanide",
  "start_marketing_date": "20180501",
  "active_numerator_strength": "2"
}

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