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United States · US · US:72578-036_54b4a378-d02a-46c6-8b82-1ed5fdea55fc
Metformin Hydrochloride
Orange BookUNIISPLATC A10BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViona Pharmaceuticals Inc
CountryUS (United States)
ATC codeA10BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc117257803601100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-036-01)
- ndc117257803605500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-036-05)
Annotations
UNII (FDA Substance ID)
786Z46389E
METFORMIN HYDROCHLORIDE
RxCUI 235743
Orange Book
A077078
AB
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": "72578-036_54b4a378-d02a-46c6-8b82-1ed5fdea55fc",
"productndc": "72578-036",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "077078",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "001",
"approval_date": "Apr 21, 2005"
}
],
"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": "ANDA077078",
"marketing_category": "ANDA",
"nonproprietary_name": "Metformin Hydrochloride",
"start_marketing_date": "20190315",
"active_numerator_strength": "750"
}Related drugs
Other records sharing ATC code A10BA02.
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- PLAbmetfina XRTarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.
- PLAbmetfina XRTarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.
- CAAG-METFORMINANGITA PHARMA INC.
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- CAAPO-METFORMIN ERAPOTEX INC
- CAAPO-METFORMIN ERAPOTEX INC
- CAAURO-METFORMINAURO PHARMA INC
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