Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
NuCare Pharmaceuticals,Inc.
NuCare Pharmaceuticals,Inc.
010632300
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Metformin Hydrochloride
Product Details
NDC Product Code
68071-3833Application Number
ANDA209882Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 18, 2025SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 850 mg in 1 1
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.