FDA.reportPublic FDA data

Acid Reducer

Product NDC
15127-340
11-digit product format
151270340
Labeler code
15127
Product ID
15127-340_9d228d53-a9ff-4391-8395-77580924fc26
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Select Brand
Application
ANDA200536
Marketing category
ANDA
Marketing start
2012-03-30
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
150 mg/1
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
15127-340-242020-01-31C16284748780-19d75b9d0-d2a3-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15127-340-24Acid Reducer1 in 1 BLISTER PACKTABLET12
15127-340-24Acid Reducer24 in 1 CARTONTABLET242

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15127-340-24EA - Each15127-340143f09aa-f7e2-4f93-b11a-d85bb0920f9012017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMACID REDUCER (RANITIDINE) TABLET [SELECT BRAND]2
RANITIDINEACTIVE MOIETY884KT10YB7ACID REDUCER (RANITIDINE) TABLET [SELECT BRAND]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACID REDUCER (RANITIDINE) TABLET [SELECT BRAND]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACID REDUCER (RANITIDINE) TABLET [SELECT BRAND]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ACID REDUCER (RANITIDINE) TABLET [SELECT BRAND]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACID REDUCER (RANITIDINE) TABLET [SELECT BRAND]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACID REDUCER (RANITIDINE) TABLET [SELECT BRAND]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACID REDUCER (RANITIDINE) TABLET [SELECT BRAND]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACID REDUCER (RANITIDINE) TABLET [SELECT BRAND]2
TALCINACTIVE INGREDIENT7SEV7J4R1UACID REDUCER (RANITIDINE) TABLET [SELECT BRAND]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACID REDUCER (RANITIDINE) TABLET [SELECT BRAND]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15127-340ACID REDUCER (RANITIDINE) TABLET [SELECT BRAND]2Legacy NDC, 2 package rows20140424_0f140a8c-8736-40bb-8869-61d9b5b985da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSN0f140a8c-8736-40bb-8869-61d9b5b985da2
198191ranitidine 150 MG Oral TabletSCD0f140a8c-8736-40bb-8869-61d9b5b985da2
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY0f140a8c-8736-40bb-8869-61d9b5b985da2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
15127-340-24151270340241 in 1 BLISTER PACKHistorical