TUZISTRA XR

Product NDC

69442-480

11-digit product format

694420480

Labeler code

69442

Product ID

69442-480_d62ef144-fd33-4e2e-b3c9-202429b7dcb7

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

codeine polistirex and chlorpheniramine polistirex

Dosage form

SUSPENSION, EXTENDED RELEASE

Route

ORAL

Labeler

Vernalis Therapeutics, Inc.

Application

NDA207768

Marketing category

NDA

Marketing start

2015-05-31

Marketing end

2019-05-31

Substance

CODEINE PHOSPHATE ANHYDROUS; CHLORPHENIRAMINE MALEATE

Active strength

15 mg/5mL; mg/5mL

Pharmacologic classes

Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]

DEA schedule

CIII

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record