alogliptin and metformin hydrochloride
These highlights do not include all the information needed to use ALOGLIPTIN AND METFORMIN HCl TABLETS safely and effectively. See full prescribing information for ALOGLIPTIN AND METFORMIN HCl TABLETS. Alogliptin and Metformin Hydrochloride Tablets, for oral use Initial U.S. Approval: 2013
Approved
Approval ID
9112d6b9-4771-4194-886d-7db887470bcc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
alogliptin and metformin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-5993
Application NumberNDA203414
Product Classification
M
Marketing Category
C73605
G
Generic Name
alogliptin and metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2022
FDA Product Classification
INGREDIENTS (11)
METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
ALOGLIPTIN BENZOATEActive
Quantity: 12.5 mg in 1 1
Code: EEN99869SC
Classification: ACTIM
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT