Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
APL HEALTHCARE LIMITED
Aurobindo Pharma Limited
650918514
Products3
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
59651-809Application Number
ANDA202640Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 15, 2023MeclizineActive
Code: HDP7W44CIOClass: ACTIBQuantity: 50 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MECLIZINE HYDROCHLORIDE
Product Details
NDC Product Code
59651-807Application Number
ANDA202640Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 15, 2023MeclizineActive
Code: HDP7W44CIOClass: ACTIBQuantity: 12.5 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MECLIZINE HYDROCHLORIDE
Product Details
NDC Product Code
59651-808Application Number
ANDA202640Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 15, 2023MeclizineActive
Code: HDP7W44CIOClass: ACTIBQuantity: 25 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT