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United States · US · US:67877-414_4fa6bd66-7f2c-4b63-9809-be460cbc2527
Metformin Hydrochloride
Orange BookUNIISPLATC A10BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeA10BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116787741401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-414-01)
- ndc116787741405500 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-414-05)
- ndc1167877414101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-414-10)
- ndc11678774143310 BLISTER PACK in 1 CARTON (67877-414-33) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc11678774149090 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-414-90)
Annotations
UNII (FDA Substance ID)
786Z46389E
METFORMIN HYDROCHLORIDE
RxCUI 235743
Orange Book
A206145
AB1AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "786Z46389E",
"rxcui": "235743",
"inchikey": "OETHQSJEHLVLGH-UHFFFAOYSA-N",
"display_name": "METFORMIN HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"1cb2b2be-595c-4e72-8d2c-c1edc7f85682": {
"match": "brand_token",
"title": "METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]",
"spl_version": "9",
"published_date": "2026-06-01"
}
},
"productid": "67877-414_4fa6bd66-7f2c-4b63-9809-be460cbc2527",
"productndc": "67877-414",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "206145",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "500MG",
"product_no": "001",
"approval_date": "Oct 22, 2018"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "002",
"approval_date": "Oct 22, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METFORMIN HYDROCHLORIDE",
"proprietary_name": "Metformin Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206145",
"marketing_category": "ANDA",
"nonproprietary_name": "Metformin Hydrochloride",
"start_marketing_date": "20181027",
"active_numerator_strength": "750"
}Related drugs
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- CAAG-METFORMINANGITA PHARMA INC.
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- CAAPO-METFORMIN ERAPOTEX INC
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