FDA.reportPublic FDA data

Ranitidine

Product NDC
71335-0342
11-digit product format
713350342
Labeler code
71335
Product ID
71335-0342_961ac613-8c19-4091-ad37-a71c23a5f8a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0342-1EA - Each71335-03427d39df07-ad7b-4ac4-98b3-bab1f4f3424812018-01-12
71335-0342-2EA - Each71335-0342f8b939be-35a6-4424-862d-8925f26111ec12018-01-12
71335-0342-3EA - Each71335-0342ad2acb42-eb4f-4901-9316-c6415dc80f9f12018-01-12
71335-0342-4EA - Each71335-034239ce16fa-b34d-4756-85ec-958d505a40fb12018-01-12
71335-0342-5EA - Each71335-0342daf113b2-9399-441e-a629-7da6e2f9e61712018-01-12
71335-0342-6EA - Each71335-034228df9321-71a6-4f49-bdaa-f41e0e7d02d212018-01-12
71335-0342-7EA - Each71335-03423ffe6dc8-a5bf-410a-8ee1-8d1e430938d012018-01-12
71335-0342-8EA - Each71335-03429b719b28-5bd2-421f-bde0-042fa7c02ae112018-01-12
71335-0342-9EA - Each71335-0342661d4d69-cf84-47f8-84a1-d597067ca07412018-01-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0342-17133503420130 TABLET, FILM COATED in 1 BOTTLE (71335-0342-1) 2009-04-220000-00-00NoNoCurrent
71335-0342-271335034202100 TABLET, FILM COATED in 1 BOTTLE (71335-0342-2) 2009-04-220000-00-00NoNoCurrent
71335-0342-37133503420360 TABLET, FILM COATED in 1 BOTTLE (71335-0342-3) 2009-04-220000-00-00NoNoCurrent
71335-0342-47133503420450 TABLET, FILM COATED in 1 BOTTLE (71335-0342-4) 2009-04-220000-00-00NoNoCurrent
71335-0342-57133503420590 TABLET, FILM COATED in 1 BOTTLE (71335-0342-5) 2009-04-220000-00-00NoNoCurrent
71335-0342-67133503420645 TABLET, FILM COATED in 1 BOTTLE (71335-0342-6) 2009-04-220000-00-00NoNoCurrent
71335-0342-771335034207120 TABLET, FILM COATED in 1 BOTTLE (71335-0342-7) 2009-04-220000-00-00NoNoCurrent
71335-0342-87133503420820 TABLET, FILM COATED in 1 BOTTLE (71335-0342-8) 2009-04-220000-00-00NoNoCurrent
71335-0342-97133503420915 TABLET, FILM COATED in 1 BOTTLE (71335-0342-9) 2009-04-220000-00-00NoNoCurrent