Ranitidine

Product NDC
43353-967
11-digit product format
433530967
Labeler code
43353
Product ID
43353-967_16943070-3f5f-49a0-a295-ad86344976b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077824
Marketing category
ANDA
Marketing start
2014-08-18
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7f54af34-be54-4c3c-894f-78df6452d747Product name320190703
ccf8541e-b7dc-e6ba-06c9-15bf143a7850Product name520190611
05700d9e-ea6f-4aab-b0ed-1488f1d85d7bProduct name120180904
2f9d4e5c-e179-490e-8c43-f19e1e0ca228Product name120160720

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-967-602023-01-30C16284748780-1f386c649-e6f8-0266-e053-dadaa90a7c1aRanitidine Tablets, USP
43353-967-802023-01-30C16284748780-1f386c649-e6f8-0266-e053-dadaa90a7c1aRanitidine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-967-60Ranitidine90 in 1 BOTTLETABLET902
43353-967-80Ranitidine180 in 1 BOTTLETABLET1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-967-60EA - Each43353-96767b19b99-2ea9-4a56-b58d-cd34bd7912ba12016-07-19
43353-967-80EA - Each43353-96772831aed-87ce-406a-a3bc-737c917fbc7f12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-967RANITIDINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 2 package rows20191231_7f3348a9-ce69-48d6-89f4-5c0e7d38a255.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSN7f3348a9-ce69-48d6-89f4-5c0e7d38a2552
198193ranitidine 300 MG Oral TabletPSN7f3348a9-ce69-48d6-89f4-5c0e7d38a2552
198191ranitidine 150 MG Oral TabletSCD7f3348a9-ce69-48d6-89f4-5c0e7d38a2552
198193ranitidine 300 MG Oral TabletSCD7f3348a9-ce69-48d6-89f4-5c0e7d38a2552
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY7f3348a9-ce69-48d6-89f4-5c0e7d38a2552
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSY7f3348a9-ce69-48d6-89f4-5c0e7d38a2552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-967-604335309676090 TABLET in 1 BOTTLE (43353-967-60) 90 tablet2014-10-100000-00-00NoNoCurrent
43353-967-8043353096780180 TABLET in 1 BOTTLE (43353-967-80) 180 tablet2014-10-010000-00-00NoNoCurrent