🇺🇸
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
- ndc116255972201100 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"strength": "2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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"strength": "5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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"
}Related drugs
Other records sharing ATC code R03CC53.
- GBBricanyl 1.5mg/5ml syrupAstraZeneca UK Ltd
- GBBricanyl 10mg/ml respirator solutionAstraZeneca UK Ltd
- GBBricanyl 2.5mg/5ml solution for injection ampoulesAstraZeneca UK Ltd
- GBBricanyl 250micrograms/dose inhalerDowelhurst Ltd
- GBBricanyl 250micrograms/dose inhalerAstraZeneca UK Ltd
- GBBricanyl 250micrograms/dose inhalerWaymade Healthcare Plc
- GBBricanyl 250micrograms/dose spacer inhalerAstraZeneca UK Ltd
- GBBricanyl 500micrograms/1ml solution for injection ampoulesAstraZeneca UK Ltd
Access this data programmatically
Query Terbutaline Sulfate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.