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United States · US · US:69452-380_4ba93003-acad-5cab-e063-6394a90afa98
Metformin Hydrochloride Oral Solution
Orange BookUNIISPLATC A10BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBionpharma Inc.,
CountryUS (United States)
ATC codeA10BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116945238055118 mL in 1 BOTTLE (69452-380-55)
- ndc116945238088473 mL in 1 BOTTLE (69452-380-88)
Annotations
UNII (FDA Substance ID)
786Z46389E
METFORMIN HYDROCHLORIDE
RxCUI 235743
Orange Book
A219151
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": "69452-380_4ba93003-acad-5cab-e063-6394a90afa98",
"productndc": "69452-380",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "219151",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG/5ML",
"product_no": "001",
"approval_date": "Apr 14, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METFORMIN HYDROCHLORIDE",
"proprietary_name": "Metformin Hydrochloride Oral Solution",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA219151",
"marketing_category": "ANDA",
"nonproprietary_name": "Metformin Hydrochloride",
"start_marketing_date": "20250728",
"active_numerator_strength": "500"
}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.
- CAAG-METFORMINANGITA PHARMA INC.
- CAAPO-METFORMIN ERAPOTEX INC
- CAAPO-METFORMIN ERAPOTEX INC
- CAAURO-METFORMINAURO PHARMA INC
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