OXAPROZIN
OXAPROZIN
Approved
Approval ID
53d958ba-7a60-461b-8622-b73831a00725
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 19, 2019
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
OXAPROZIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-178
Application NumberANDA075844
Product Classification
M
Marketing Category
C73584
G
Generic Name
OXAPROZIN
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2019
FDA Product Classification
INGREDIENTS (9)
METHYLCELLULOSE (400 MPA.S)Inactive
Code: O0GN6F9B2Y
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
OXAPROZINActive
Quantity: 600 mg in 1 1
Code: MHJ80W9LRB
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
OXAPROZIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-673
Application NumberANDA075845
Product Classification
M
Marketing Category
C73584
G
Generic Name
OXAPROZIN
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2019
FDA Product Classification
INGREDIENTS (11)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
METHYLCELLULOSE (100 MPA.S)Inactive
Code: 4GFU244C4J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
OXAPROZINActive
Quantity: 600 mg in 1 1
Code: MHJ80W9LRB
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT