Ranitidine

Product NDC
71821-002
11-digit product format
718210002
Labeler code
71821
Product ID
71821-002_b9878674-e349-4222-8dee-b026f4f0c5b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
VKT Pharma Private Limited
Application
ANDA211289
Marketing category
ANDA
Marketing start
2019-02-18
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
71821-002-012021-01-29C16284748780-1ba0f9c33-575d-a910-e053-dadaa90a0b85RANITIDINE TABLETS USP, 150 mg RANITIDINE TABLETS USP, 300 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71821-002-01Ranitidine250 in 1 CONTAINERTABLET, FILM COATED2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71821-002RANITIDINE TABLET, FILM COATED [VKT PHARMA PRIVATE LIMITED]1Legacy NDC, 1 package rows20190220_a9f506bf-21ef-4323-9ce8-e8a7b561c496.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSNa9f506bf-21ef-4323-9ce8-e8a7b561c4961
198193ranitidine 300 MG Oral TabletPSNa9f506bf-21ef-4323-9ce8-e8a7b561c4961
198191ranitidine 150 MG Oral TabletSCDa9f506bf-21ef-4323-9ce8-e8a7b561c4961
198193ranitidine 300 MG Oral TabletSCDa9f506bf-21ef-4323-9ce8-e8a7b561c4961
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYa9f506bf-21ef-4323-9ce8-e8a7b561c4961
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSYa9f506bf-21ef-4323-9ce8-e8a7b561c4961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
71821-002-0171821000201250 in 1 CONTAINERHistorical