STEGLATRO
These highlights do not include all the information needed to use STEGLATRO safely and effectively. See full prescribing information for STEGLATRO. STEGLATRO (ertugliflozin) tablets, for oral useInitial U.S. Approval: 2017
Approved
Approval ID
2e32d778-54ca-4bd8-b61a-236208f36e98
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2024
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.
ertugliflozin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-6183
Application NumberNDA209803
Product Classification
M
Marketing Category
C73594
G
Generic Name
ertugliflozin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2023
FDA Product Classification
INGREDIENTS (10)
ERTUGLIFLOZIN PIDOLATEActive
Quantity: 15 mg in 1 1
Code: MLU731K321
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT