Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
NCS HealthCare of KY, LLC dba Vangard Labs
NCS HealthCare of KY, LLC dba Vangard Labs
050052943
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PredniSONE
Product Details
NDC Product Code
0615-8391Application Number
ANDA084122Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 2, 2022PrednisoneActive
Code: VB0R961HZTClass: ACTIBQuantity: 10 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Prednisone
Product Details
NDC Product Code
0615-8395Application Number
ANDA080352Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 2, 2022PrednisoneActive
Code: VB0R961HZTClass: ACTIBQuantity: 5 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT