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United States · US · US:62135-524_459ef32e-2348-14bd-e063-6394a90a6a90
Terbutaline Sulfate
Orange BookUNIISPLATC R03CC53
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChartwell RX, LLC.
CountryUS (United States)
ATC codeR03CC53
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11621355249090 TABLET in 1 BOTTLE (62135-524-90)
Annotations
UNII (FDA Substance ID)
576PU70Y8E
TERBUTALINE SULFATE
RxCUI 10369
Orange Book
A077152
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": "62135-524_459ef32e-2348-14bd-e063-6394a90a6a90",
"productndc": "62135-524",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "077152",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2.5MG",
"product_no": "001",
"approval_date": "Mar 25, 2005"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "002",
"approval_date": "Mar 25, 2005"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TERBUTALINE SULFATE",
"proprietary_name": "Terbutaline Sulfate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077152",
"marketing_category": "ANDA",
"nonproprietary_name": "Terbutaline Sulfate",
"start_marketing_date": "20050325",
"active_numerator_strength": "2.5"
}Related drugs
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