Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Epic Pharm LLC
827915443
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Epic Pharma LLC
Epic Pharma LLC
Epic Pharm LLC
827915443
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Meclizine Hydrochloride
Product Details
NDC Product Code
42806-012Application Number
ANDA200294Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 21, 2020MeclizineActive
Code: HDP7W44CIOClass: ACTIBQuantity: 12.5 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
Meclizine Hydrochloride
Product Details
NDC Product Code
42806-014Application Number
ANDA200294Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 21, 2020MeclizineActive
Code: HDP7W44CIOClass: ACTIBQuantity: 25 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT