FDA.reportPublic FDA data

Ranitidine

Product NDC
33261-202
11-digit product format
332610202
Labeler code
33261
Product ID
33261-202_99a8f78f-d074-4c2a-8dff-b0637b2a2324
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA077824
Marketing category
ANDA
Marketing start
2009-12-16
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
2019-12-31
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
33261-202-002020-01-31C16284748780-19d75b9d0-c613-f424-e053-dadaa90a57ceRanitidine Tablets, USP
33261-202-022020-01-31C16284748780-19d75b9d0-c613-f424-e053-dadaa90a57ceRanitidine Tablets, USP
33261-202-302020-01-31C16284748780-19d75b9d0-c613-f424-e053-dadaa90a57ceRanitidine Tablets, USP
33261-202-602020-01-31C16284748780-19d75b9d0-c613-f424-e053-dadaa90a57ceRanitidine Tablets, USP
33261-202-902020-01-31C16284748780-19d75b9d0-c613-f424-e053-dadaa90a57ceRanitidine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-202-00Ranitidine100 in 1 BOTTLETABLET1007
33261-202-02Ranitidine120 in 1 BOTTLETABLET1207
33261-202-30Ranitidine30 in 1 BOTTLETABLET307
33261-202-60Ranitidine60 in 1 BOTTLETABLET607
33261-202-90Ranitidine90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-202-00EA - Each33261-2029fc6b1d7-c932-4797-b893-c0ce0881ae5712017-12-14
33261-202-02EA - Each33261-2026ba72666-68dd-4b4a-9f7e-dff0c24e614212015-10-02
33261-202-30EA - Each33261-202c120a0c4-6ede-4ab2-9bc0-616642274a1b12015-10-02
33261-202-60EA - Each33261-202a9419eb8-2709-4ef8-8cb6-36d2644c3dd412015-10-02
33261-202-90EA - Each33261-2023e7578a4-c346-4252-a704-01ce313bad0612015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMRANITIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]2
RANITIDINEACTIVE MOIETY884KT10YB7RANITIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-202RANITIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]7Legacy NDC, 5 package rows20171117_9add19e6-f71c-4950-ae63-90e152a9cfe0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSN9add19e6-f71c-4950-ae63-90e152a9cfe07
198193ranitidine 300 MG Oral TabletPSN9add19e6-f71c-4950-ae63-90e152a9cfe07
198191ranitidine 150 MG Oral TabletSCD9add19e6-f71c-4950-ae63-90e152a9cfe07
198193ranitidine 300 MG Oral TabletSCD9add19e6-f71c-4950-ae63-90e152a9cfe07
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY9add19e6-f71c-4950-ae63-90e152a9cfe07
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSY9add19e6-f71c-4950-ae63-90e152a9cfe07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-202-0033261020200100 in 1 BOTTLEHistorical
33261-202-0233261020202120 in 1 BOTTLEHistorical
33261-202-303326102023030 in 1 BOTTLEHistorical
33261-202-603326102026060 in 1 BOTTLEHistorical
33261-202-903326102029090 in 1 BOTTLEHistorical