DUO Fusion

Product NDC

0597-0320

11-digit product format

005970320

Labeler code

0597

Product ID

0597-0320_f4b7ba25-e6fd-9cd9-707a-6526ae37e96b

Type

HUMAN OTC DRUG

Nonproprietary name

Famotidine, Calcium carbonate, Magnesium hydroxide

Dosage form

TABLET, CHEWABLE

Route

ORAL

Labeler

Boehringer Ingelheim Pharmaceuticals, Inc.

Application

ANDA077355

Marketing category

ANDA

Marketing start

2016-03-01

Marketing end

0000-00-00

Substance

FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE

Active strength

10 mg/1; mg/1; mg/1

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record