MAXIMUM STRENGTH RANITIDINE

Product NDC
57243-280
11-digit product format
572430280
Labeler code
57243
Product ID
57243-280_9d8259f1-db0e-4c4e-a803-e3901307a2c9
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
McLane Company, Inc.
Application
ANDA207578
Marketing category
ANDA
Marketing start
2017-11-13
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
150 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57243-280-08572430280081 BOTTLE in 1 CARTON (57243-280-08) > 24 TABLET in 1 BOTTLE1 bottle2017-11-130000-00-00NoNoCurrent