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United States · US · US:24979-132_3fd94b35-ef5a-4eb3-a3bd-0ce7572521d6
Terbutaline Sulfate
Orange BookUNIISPLATC R03CC53
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeR03CC53
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc112497913201100 TABLET in 1 BOTTLE (24979-132-01)
- ndc1124979132031000 TABLET in 1 BOTTLE (24979-132-03)
Annotations
UNII (FDA Substance ID)
576PU70Y8E
TERBUTALINE SULFATE
RxCUI 10369
Orange Book
A211832
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": "24979-132_3fd94b35-ef5a-4eb3-a3bd-0ce7572521d6",
"productndc": "24979-132",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211832",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2.5MG",
"product_no": "001",
"approval_date": "Jun 19, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "002",
"approval_date": "Jun 19, 2020"
}
],
"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": "ANDA211832",
"marketing_category": "ANDA",
"nonproprietary_name": "Terbutaline Sulfate",
"start_marketing_date": "20200713",
"active_numerator_strength": "2.5"
}Related drugs
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