Nizatidine

Product NDC
68258-3006
11-digit product format
682583006
Labeler code
68258
Product ID
68258-3006_26c7935e-4425-4a24-a7af-caa1db3585a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nizatidine
Dosage form
CAPSULE
Route
ORAL
Labeler
Dispensing Solutions Inc.
Application
ANDA075616
Marketing category
ANDA
Marketing start
2009-01-22
Marketing end
0000-00-00
Substance
NIZATIDINE
Active strength
300 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
68258-3006-12019-10-21C16284748780-1956f9ecf-de84-621f-e053-dbdaa90a74adNizatidine Capsules USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-3006-1Nizatidine30 in 1 BOTTLE, PLASTICCAPSULE301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NizatidineACTIVE INGREDIENTP41PML4GHRNIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]1
NizatidineACTIVE MOIETYP41PML4GHRNIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XNIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]1
GELATININACTIVE INGREDIENT2G86QN327LNIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TNIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]1
SHELLACINACTIVE INGREDIENT46N107B71ONIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-3006NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]1Legacy NDC, 1 package rows20100315_3666b5f5-cdcf-42be-a67d-226603435d08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198041nizatidine 300 MG Oral CapsulePSN3666b5f5-cdcf-42be-a67d-226603435d081
198041nizatidine 300 MG Oral CapsuleSCD3666b5f5-cdcf-42be-a67d-226603435d081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68258-3006-16825830060130 in 1 BOTTLE, PLASTICHistorical