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United States · US · US:71205-938_9f8ee6b8-61e1-478a-90de-57358fdb5905
Terbutaline Sulfate
Orange BookUNIISPLATC R03CC53
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeR03CC53
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc117120593800100 TABLET in 1 BOTTLE (71205-938-00)
- ndc11712059383030 TABLET in 1 BOTTLE (71205-938-30)
- ndc117120593855500 TABLET in 1 BOTTLE (71205-938-55)
- ndc11712059386060 TABLET in 1 BOTTLE (71205-938-60)
- ndc11712059389090 TABLET in 1 BOTTLE (71205-938-90)
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": "71205-938_9f8ee6b8-61e1-478a-90de-57358fdb5905",
"productndc": "71205-938",
"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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