Carbinoxamine Maleate

Basic Information

Product Name

FDA Product Code

64950-243

Regulatory Information

NDC Product Code

64950-243

Application Number

ANDA040458

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

Carbinoxamine Maleate

Quantity: 4 mg in 5 mL

Code: 02O55696WH

Class Code: ACTIB

Anhydrous Citric Acid

Code: XF417D3PSL

Class Code: IACT

Glycerin

Code: PDC6A3C0OX

Class Code: IACT

Methylparaben

Code: A2I8C7HI9T

Class Code: IACT

Propylene Glycol

Code: 6DC9Q167V3

Class Code: IACT

SODIUM CITRATE, UNSPECIFIED FORM

Code: 1Q73Q2JULR

Class Code: IACT

Sorbitol

Code: 506T60A25R

Class Code: IACT

Propylparaben

Code: Z8IX2SC1OH

Class Code: IACT

Water

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

Carbinoxamine

Code: 982A7M02H5

Basic Information

Regulatory Information

Company Information

Active Ingredients

Anhydrous Citric Acid

Glycerin

Methylparaben

Propylene Glycol

SODIUM CITRATE, UNSPECIFIED FORM

Sorbitol

Propylparaben

Water

Active Moieties

Carbinoxamine