Nizatidine

Product NDC
68151-0017
11-digit product format
681510017
Labeler code
68151
Product ID
68151-0017_f9160ff8-03c7-40a6-9264-ec9b8e818e10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nizatidine
Dosage form
CAPSULE
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA075616
Marketing category
ANDA
Marketing start
2002-07-09
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
E
Listing certified through
2018-12-31
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
68151-0017-62020-01-31C16284748780-19d75b9d1-0fc9-f424-e053-dadaa90a57ceNizatidine Capsules 150 mg and 300 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-0017-6Nizatidine1 in 1 BOTTLECAPSULE14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIZATIDINEACTIVE INGREDIENTP41PML4GHRNIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
NIZATIDINEACTIVE MOIETYP41PML4GHRNIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XNIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LNIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TNIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SHELLACINACTIVE INGREDIENT46N107B71ONIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-0017NIZATIDINE CAPSULE [CARILION MATERIALS MANAGEMENT]4Legacy NDC, 1 package rows20170706_005909e4-77d2-440f-a10b-30fab27ffbc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312025nizatidine 150 MG Oral CapsulePSN005909e4-77d2-440f-a10b-30fab27ffbc34
312025nizatidine 150 MG Oral CapsuleSCD005909e4-77d2-440f-a10b-30fab27ffbc34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-0017-6681510017061 in 1 BOTTLEHistorical