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United States · US · US:62559-722_ee722f8c-05d6-43bc-825d-9496579032c4

Terbutaline Sulfate

Orange BookUNIISPLATC R03CC53

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

Identification

ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR03CC53
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6255972201
    100 TABLET in 1 BOTTLE (62559-722-01)

Annotations

UNII (FDA Substance ID)
576PU70Y8E
TERBUTALINE SULFATE
RxCUI 10369
Orange Book
N017849
ABAB
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": "ORAL",
  "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": "62559-722_ee722f8c-05d6-43bc-825d-9496579032c4",
  "productndc": "62559-722",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "017849",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TERBUTALINE SULFATE",
  "proprietary_name": "Terbutaline Sulfate",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA017849",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Terbutaline Sulfate",
  "start_marketing_date": "20181016",
  "active_numerator_strength": "5"
}

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