Nizatidine

Product NDC
45865-374
11-digit product format
458650374
Labeler code
45865
Product ID
45865-374_1d6161e3-2dda-5446-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nizatidine
Dosage form
CAPSULE
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA090618
Marketing category
ANDA
Marketing start
2011-07-15
Marketing end
0000-00-00
Substance
NIZATIDINE
Active strength
150 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
5c362336-b506-4bdc-6f70-74c97a4a3342Product name120140508
6f755c6f-b906-f8da-e39d-305610ef9195Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-374-602020-01-31C16284748780-19d75b9d0-79e7-f424-e053-dadaa90a57ceNizatidine Capsules USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-374-60Nizatidine60 in 1 BOTTLECAPSULE601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIZATIDINEACTIVE INGREDIENTP41PML4GHRNIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS]1
NIZATIDINEACTIVE MOIETYP41PML4GHRNIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS]1
GELATININACTIVE INGREDIENT2G86QN327LNIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-374NIZATIDINE CAPSULE [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20150819_1d6161e3-2ddb-5446-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312025nizatidine 150 MG Oral CapsulePSN1d6161e3-2ddb-5446-e054-00144ff8d46c1
312025nizatidine 150 MG Oral CapsuleSCD1d6161e3-2ddb-5446-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-374-604586503746060 in 1 BOTTLEHistorical