Nizatidine

Product NDC

0378-5300

11-digit product format

003785300

Labeler code

0378

Product ID

0378-5300_1510df83-b013-4280-b49b-d0d2a23e86d4

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

nizatidine

Dosage form

CAPSULE

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA075806

Marketing category

ANDA

Marketing start

2002-07-10

Marketing end

2020-08-31

Substance

NIZATIDINE

Active strength

300 mg/1

Pharmacologic classes

Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record