Ranitidine

Product NDC
43353-971
11-digit product format
433530971
Labeler code
43353
Product ID
43353-971_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
150 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
43353-971-302023-01-30C16284748780-1f386c649-e6f8-0266-e053-dadaa90a7c1aRanitidine Tablets, USP
43353-971-602023-01-30C16284748780-1f386c649-e6f8-0266-e053-dadaa90a7c1aRanitidine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-971-30Ranitidine30 in 1 BOTTLETABLET302
43353-971-60Ranitidine90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-971-30EA - Each43353-9714341235c-505d-4617-a415-d570dc79635d12016-07-19
43353-971-60EA - Each43353-971dae31561-6424-4d2c-be31-3ff2453a68e412016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-971RANITIDINE 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
43353-971-304335309713030 TABLET in 1 BOTTLE (43353-971-30) 30 tablet2014-10-220000-00-00NoNoCurrent
43353-971-604335309716090 TABLET in 1 BOTTLE (43353-971-60) 90 tablet2014-10-090000-00-00NoNoCurrent