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United States · US · US:72789-131_2c2501a6-a6d6-1d6c-e063-6294a90ad428
Acarbose
Orange BookUNIISPLATC A10BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA10BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11727891313030 TABLET in 1 BOTTLE, PLASTIC (72789-131-30)
- ndc11727891316060 TABLET in 1 BOTTLE, PLASTIC (72789-131-60)
- ndc11727891319090 TABLET in 1 BOTTLE, PLASTIC (72789-131-90)
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": "72789-131_2c2501a6-a6d6-1d6c-e063-6294a90ad428",
"productndc": "72789-131",
"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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