CIMETIDINE HYDROCHLORIDE

Product NDC
50383-966
11-digit product format
503830966
Labeler code
50383
Product ID
50383-966_478a5f78-dd99-4476-9c97-b963da080c3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CIMETIDINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Akorn
Application
ANDA074664
Marketing category
ANDA
Marketing start
2020-10-29
Marketing end
0000-00-00
Substance
CIMETIDINE HYDROCHLORIDE
Active strength
300 mg/5mL
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8f48ba86-02a3-4def-9efa-3a8140fd7adfProduct name220250624
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-966-082024-01-30C16284748780-11030e365-2473-111a-e063-dadaa90a10e2CIMETIDINE HYDROCHLORIDE ORAL SOLUTION, 300 mg/ 5 mL Rx only Rev.966:00 02/19

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-966-08CIMETIDINE HYDROCHLORIDE273 mL in 1 BOTTLESOLUTION2732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-966CIMETIDINE HYDROCHLORIDE SOLUTION [AKORN]2Legacy NDC, 1 package rows20220308_b27f10b3-3913-401c-90a4-f92dc5de763e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
212787cimetidine HCl 300 MG in 5 mL Oral SolutionPSNb27f10b3-3913-401c-90a4-f92dc5de763e2
212787cimetidine 60 MG/ML Oral SolutionSCDb27f10b3-3913-401c-90a4-f92dc5de763e2
212787cimetidine 300 MG per 5 ML Oral SolutionSYb27f10b3-3913-401c-90a4-f92dc5de763e2
212787cimetidine 400 MG per 6.7 ML Oral SolutionSYb27f10b3-3913-401c-90a4-f92dc5de763e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-966-0850383096608273 mL in 1 BOTTLE (50383-966-08) 273 ml2020-10-290000-00-00NoNoCurrent