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United States · US · US:0054-0140_2d7f6918-65c3-4db3-b775-b74e1e637cea
Acarbose
Orange BookUNIISPLATC A10BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeA10BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110054014025100 TABLET in 1 BOTTLE (0054-0140-25)
Annotations
UNII (FDA Substance ID)
T58MSI464G
ACARBOSE
RxCUI 16681
Orange Book
A078470
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": "0054-0140_2d7f6918-65c3-4db3-b775-b74e1e637cea",
"productndc": "0054-0140",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078470",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "May 7, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "May 7, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "003",
"approval_date": "May 7, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACARBOSE",
"proprietary_name": "Acarbose",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078470",
"marketing_category": "ANDA",
"nonproprietary_name": "Acarbose",
"start_marketing_date": "20080507",
"active_numerator_strength": "25"
}Related drugs
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