MOXATAG

Product NDC

69442-030

11-digit product format

694420030

Labeler code

69442

Product ID

69442-030_c48c2f61-87df-4c6b-acfa-383bb8348b0a

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

amoxicillin

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

Vernalis Therapeutics, Inc.

Application

NDA050813

Marketing category

NDA

Marketing start

2016-01-15

Marketing end

2019-09-30

Substance

AMOXICILLIN

Active strength

775 mg/1

Pharmacologic classes

Penicillin-class Antibacterial [EPC],Penicillins [CS]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record