NDC 0615-8105

Metformin Hydrochoride

Metformin

Metformin Hydrochoride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Llc Dba Vangard Labs. The primary component is Metformin Hydrochloride.

Product ID0615-8105_02d72da7-3128-4811-b337-f22354d03d90
NDC0615-8105
Product TypeHuman Prescription Drug
Proprietary NameMetformin Hydrochoride
Generic NameMetformin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2005-01-14
Marketing CategoryANDA / ANDA
Application NumberANDA077095
Labeler NameNCS HealthCare of KY, LLC dba Vangard Labs
Substance NameMETFORMIN HYDROCHLORIDE
Active Ingredient Strength850 mg/1
Pharm ClassesBiguanide [EPC], Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0615-8105-39

30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8105-39)
Marketing Start Date2005-01-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-8105-39 [00615810539]

Metformin Hydrochoride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077095
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-01-14

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE850 mg/1

OpenFDA Data

SPL SET ID:23aa0072-365c-4d13-9aa7-ae23f7e00ee4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861007
  • 861010
  • 861004

    • Pharmacological Class

    • Biguanide [EPC]
    • Biguanides [CS]

    NDC Crossover Matching brand name "Metformin Hydrochoride" or generic name "Metformin"

    NDCBrand NameGeneric Name
    0615-8105Metformin HydrochorideMetformin
    50742-633Metforminmetformin
    50742-634Metforminmetformin
    0378-6001Metformin Hydrochloridemetformin
    0378-6002Metformin Hydrochloridemetformin
    65162-174Metformin HydrochlorideMetformin
    65162-175Metformin HydrochlorideMetformin
    65162-177Metformin HydrochlorideMetformin
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.