FDA.reportPublic FDA data

ACID REDUCER

Product NDC
63941-351
11-digit product format
639410351
Labeler code
63941
Product ID
63941-351_c4f63f37-715b-462a-b5fb-a7bc58461de5
Type
HUMAN OTC DRUG
Nonproprietary name
Ranitidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Valu Merchandisers Company
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
63941-351-082020-01-31C16284748780-19d75b9d0-ff88-f424-e053-dadaa90a57ceDrug Facts
63941-351-242020-01-31C16284748780-19d75b9d0-ff88-f424-e053-dadaa90a57ceDrug Facts
63941-351-502020-01-31C16284748780-19d75b9d0-ff88-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-351-08ACID REDUCER8 in 1 CARTONTABLET82
63941-351-08ACID REDUCER1 in 1 BLISTER PACKTABLET12
63941-351-24ACID REDUCER1 in 1 BLISTER PACKTABLET12
63941-351-24ACID REDUCER24 in 1 CARTONTABLET242
63941-351-50ACID REDUCER50 in 1 BOTTLETABLET502
63941-351-50ACID REDUCER1 in 1 CARTONTABLET12

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-351ACID REDUCER (RANITIDINE HYDROCHLORIDE) TABLET [VALU MERCHANDISERS COMPANY]2Legacy NDC, 6 package rows20140423_e71e9a8c-62b4-4361-85ce-5841ee672cff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSNe71e9a8c-62b4-4361-85ce-5841ee672cff2
198191ranitidine 150 MG Oral TabletSCDe71e9a8c-62b4-4361-85ce-5841ee672cff2
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSYe71e9a8c-62b4-4361-85ce-5841ee672cff2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63941-351-08639410351088 in 1 CARTONHistorical
63941-351-24639410351241 in 1 BLISTER PACKHistorical
63941-351-506394103515050 in 1 BOTTLEHistorical