Carbinoxamine Maleate

Basic Information

Product Name

FDA Product Code

64950-211

Regulatory Information

NDC Product Code

64950-211

Application Number

ANDA040442

Marketing Category

C73584

Effective Date

March 11, 2024

Territorial Authority

USA

FDA Title

Carbinoxamine Maleate Tablets, USP 4 mg Carbinoxamine Maleate Oral Solution, 4 mg/5 mL

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

Microcrystalline Cellulose

Code: OP1R32D61U

Class Code: IACT

Anhydrous Lactose

Code: 3SY5LH9PMK

Class Code: IACT

Carbinoxamine Maleate

Quantity: 4 mg in 1 1

Code: 02O55696WH

Class Code: ACTIB

Magnesium Stearate

Code: 70097M6I30

Class Code: IACT

Sodium Starch Glycolate Type A Potato

Code: 5856J3G2A2

Class Code: IACT

Active Moieties

Carbinoxamine

Code: 982A7M02H5

Basic Information

Regulatory Information

Company Information

Active Ingredients

Microcrystalline Cellulose

Anhydrous Lactose

Magnesium Stearate

Sodium Starch Glycolate Type A Potato

Active Moieties

Carbinoxamine