Nizatidine

Product NDC
63187-249
11-digit product format
631870249
Labeler code
63187
Product ID
63187-249_7d51448b-bb0d-40f3-a360-e15a2d5631fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nizatidine
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-249NIZATIDINE CAPSULE [PROFICIENT RX LP]3Legacy NDC20210116_1a528236-6375-4630-b4e1-8db250a4cbef.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-249-606318702496060 CAPSULE in 1 BOTTLE (63187-249-60) 60 capsule2019-01-010000-00-00NoNoCurrent