FDA Product

Carbinoxamine Maleate

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Carbinoxamine Maleate

FDA Product Code

51991-334

Regulatory Information

NDC Product Code

51991-334

Application Number

ANDA040458

Marketing Category

C73584

Effective Date

September 23, 2022

Territorial Authority

USA

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

8

Company Information

ManufacturerBreckenridge Pharmaceutical, Inc.

DUNS Number

150554335

Active Ingredients

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

PROPYLPARABEN

Code: Z8IX2SC1OH

Class Code: IACT

CARBINOXAMINE MALEATE

Quantity: 4 mg in 5 mL

Code: 02O55696WH

Class Code: ACTIB

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

SODIUM CITRATE

Code: 1Q73Q2JULR

Class Code: IACT

SORBITOL

Code: 506T60A25R

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

CARBINOXAMINE

Code: 982A7M02H5

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