FDA.reportPublic FDA data

ACID REDUCER

Product NDC
63868-487
11-digit product format
638680487
Labeler code
63868
Product ID
63868-487_101b4abe-d563-46bd-b6af-2c16116d3ed3
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Chain Drug Marketing Association Inc.
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
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
63868-487-242020-01-31C16284748780-19d75b9d0-22ba-f424-e053-dadaa90a57ceDrug Facts
63868-487-502020-01-31C16284748780-19d75b9d0-22ba-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-487-24ACID REDUCER1 in 1 BLISTER PACKTABLET12
63868-487-24ACID REDUCER24 in 1 CARTONTABLET242
63868-487-50ACID REDUCER1 in 1 CARTONTABLET12
63868-487-50ACID REDUCER50 in 1 BOTTLETABLET502

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-487ACID REDUCER (RANITIDINE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC.]2Legacy NDC, 4 package rows20140424_1f5bb3a1-95f9-4c08-b370-b3f830e3abf4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSN1f5bb3a1-95f9-4c08-b370-b3f830e3abf42
198191ranitidine 150 MG Oral TabletSCD1f5bb3a1-95f9-4c08-b370-b3f830e3abf42
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY1f5bb3a1-95f9-4c08-b370-b3f830e3abf42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63868-487-24638680487241 in 1 BLISTER PACKHistorical
63868-487-50638680487501 in 1 CARTONHistorical