Betaxolol
Betaxolol Tablets USP, Film-Coated
Approved
Approval ID
bf716efe-0a9f-43b1-9d8a-c69330b82e18
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2019
Manufacturers
FDA
Epic Pharma LLC
DUNS: 827915443
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Betaxolol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-038
Application NumberANDA075541
Product Classification
M
Marketing Category
C73584
G
Generic Name
Betaxolol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2019
FDA Product Classification
INGREDIENTS (11)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
BETAXOLOL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 6X97D2XT0O
Classification: ACTIB
Betaxolol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-039
Application NumberANDA075541
Product Classification
M
Marketing Category
C73584
G
Generic Name
Betaxolol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2019
FDA Product Classification
INGREDIENTS (11)
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BETAXOLOL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 6X97D2XT0O
Classification: ACTIB
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT