Dobutamine Hydrochloride in Dextrose

In shortageOrange BookUNIISPLATC C01CA07

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

Identification

ManufacturerBaxter Healthcare Corporation

CountryUS (United States)

ATC codeC01CA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0338107702
18 BAG in 1 CARTON (0338-1077-02) / 250 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

0WR771DJXV

DOBUTAMINE HYDROCHLORIDE

RxCUI 203121

Orange Book

N020255

APAPAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Dobutamine Hydrochloride Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "0WR771DJXV",
    "rxcui": "203121",
    "inchikey": "BQKADKWNRWCIJL-UHFFFAOYSA-N",
    "display_name": "DOBUTAMINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "52f70858-7cf9-2ff1-e063-6294a90ac46c": {
      "match": "brand_token",
      "title": "DOBUTAMINE IN DEXTROSE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0338-1077_34c787c1-46f7-4264-951d-c88a34dca533",
  "productndc": "0338-1077",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "020255",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 50MG BASE/100ML",
        "product_no": "001",
        "approval_date": "Oct 19, 1993"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 100MG BASE/100ML",
        "product_no": "003",
        "approval_date": "Oct 19, 1993"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 200MG BASE/100ML",
        "product_no": "004",
        "approval_date": "Oct 19, 1993"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 400MG BASE/100ML",
        "product_no": "005",
        "approval_date": "Oct 19, 1993"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOBUTAMINE HYDROCHLORIDE",
  "shortage_reason": "Dobutamine Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Dobutamine Hydrochloride in Dextrose",
  "active_ingred_unit": "mg/100mL",
  "application_number": "NDA020255",
  "marketing_category": "NDA",
  "nonproprietary_name": "Dobutamine Hydrochloride",
  "start_marketing_date": "19930923",
  "active_numerator_strength": "400"
}

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