🇺🇸
United States · US · US:64380-759_771efa63-fb94-4850-a777-1e876066d073
Acarbose
Orange BookUNIISPLATC A10BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC codeA10BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116438075906100 TABLET in 1 BOTTLE, PLASTIC (64380-759-06)
Annotations
UNII (FDA Substance ID)
T58MSI464G
ACARBOSE
RxCUI 16681
Orange Book
A090912
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "T58MSI464G",
"rxcui": "16681",
"inchikey": "CEMXHAPUFJOOSV-XGWNLRGSSA-N",
"display_name": "ACARBOSE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"d1b627e1-d78d-47dd-93f5-2bf4998466ba": {
"match": "brand_token",
"title": "ACARBOSE TABLET [CHARTWELL RX, LLC]",
"spl_version": "3",
"published_date": "2025-12-10"
}
},
"productid": "64380-759_771efa63-fb94-4850-a777-1e876066d073",
"productndc": "64380-759",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "090912",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Jul 27, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Jul 27, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "003",
"approval_date": "Jul 27, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACARBOSE",
"proprietary_name": "Acarbose",
"active_ingred_unit": "mg/1",
"application_number": "ANDA090912",
"marketing_category": "ANDA",
"nonproprietary_name": "acarbose",
"start_marketing_date": "20161210",
"active_numerator_strength": "50"
}Related drugs
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