Ranitidine

Product NDC

55289-505

11-digit product format

552890505

Labeler code

55289

Product ID

55289-505_7c4adfd3-ed45-e2cb-e053-2991aa0a519d

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Ranitidine

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

PD-Rx Pharmaceuticals, Inc.

Application

ANDA075165

Marketing category

ANDA

Marketing start

1998-04-01

Marketing end

0000-00-00

Substance

RANITIDINE HYDROCHLORIDE

Active strength

300 mg/1

Pharmacologic classes

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

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record