Ranitidine

Product NDC

68071-3165

11-digit product format

680713165

Labeler code

68071

Product ID

68071-3165_84a0158f-3a4b-9472-e053-2991aa0abaed

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Ranitidine

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

NuCare Pharmaceuticals, Inc.

Application

ANDA078542

Marketing category

ANDA

Marketing start

2008-11-19

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

2020-12-31

Current FDA listing

Historical FDA.report record