Glipizide and Metformin HCl
Glipizide and Metformin HCl Tablets USP These highlights do not include all the information needed to use Glipizide and Metformin HCl safely and effectively. See full prescribing information for Glipizide and Metformin HCl Glipizide and Metformin HCl (Glipizide and Metformin HCl) TABLET, FILM COATED for ORAL use. Initial U.S. Approval:
Approved
Approval ID
be4d2552-c964-4d09-ba7a-0d94320f968c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2019
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Glipizide and Metformin HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71205-270
Application NumberANDA078728
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glipizide and Metformin HCl
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2019
FDA Product Classification
INGREDIENTS (13)
GLIPIZIDEActive
Quantity: 5 mg in 1 1
Code: X7WDT95N5C
Classification: ACTIB
METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT