Cimetidine

Product NDC
53002-3280
11-digit product format
530023280
Labeler code
53002
Product ID
53002-3280_b6b2beae-297e-446e-99db-03ffff418942
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cimetidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA074151
Marketing category
ANDA
Marketing start
2003-11-24
Marketing end
0000-00-00
Substance
CIMETIDINE
Active strength
300 mg/1
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-3280-32025-01-30C16284748780-12cef2736-b5fd-d83d-e063-dadaa90ab31fCIMETIDINE TABLETS USP 8192 8204 8305 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-3280-3Cimetidine30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3280CIMETIDINE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20220331_b235425c-1824-4e91-ac8d-5d6f745e3cdd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197506cimetidine 300 MG Oral TabletPSNb235425c-1824-4e91-ac8d-5d6f745e3cdd1
197506cimetidine 300 MG Oral TabletSCDb235425c-1824-4e91-ac8d-5d6f745e3cdd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-3280-35300232800330 TABLET, FILM COATED in 1 BOTTLE (53002-3280-3) 2022-10-010000-00-00NoNoCurrent