Terbutaline Sulfate

Orange BookUNIISPLATC R03CC53

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeR03CC53

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6332366501
25 VIAL, SINGLE-USE in 1 TRAY (63323-665-01) / 1 mL in 1 VIAL, SINGLE-USE (63323-665-00)

Annotations

UNII (FDA Substance ID)

576PU70Y8E

TERBUTALINE SULFATE

RxCUI 10369

Orange Book

A076887

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "576PU70Y8E",
    "rxcui": "10369",
    "inchikey": "KFVSLSTULZVNPG-UHFFFAOYSA-N",
    "display_name": "TERBUTALINE SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "859267c6-3d14-4123-9b9d-4fc248f09726": {
      "match": "brand_token",
      "title": "TERBUTALINE SULFATE TABLET [CHARTWELL RX, LLC.]",
      "spl_version": "2",
      "published_date": "2025-12-12"
    }
  },
  "productid": "63323-665_15846c75-dc60-4339-b97b-5c9d78d66cf1",
  "productndc": "63323-665",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "076887",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "May 26, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TERBUTALINE SULFATE",
  "proprietary_name": "Terbutaline Sulfate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA076887",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TERBUTALINE SULFATE",
  "start_marketing_date": "20110310",
  "active_numerator_strength": "1"
}

Related drugs

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