FDA.reportPublic FDA data

nizatidine

Product NDC
21695-375
11-digit product format
216950375
Labeler code
21695
Product ID
21695-375_0131d303-52c4-4ea7-a560-b529bb2c1616
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nizatidine
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA076178
Marketing category
ANDA
Marketing start
2002-07-05
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
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
5c362336-b506-4bdc-6f70-74c97a4a3342Product name120140508
6f755c6f-b906-f8da-e39d-305610ef9195Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-375-142019-09-24C16284748780-1934fe258-4bae-48b1-e053-8cdaa90a720aNizatidine Capsules USP
21695-375-282019-09-24C16284748780-1934fe258-4bae-48b1-e053-8cdaa90a720aNizatidine Capsules USP
21695-375-602019-09-24C16284748780-1934fe258-4bae-48b1-e053-8cdaa90a720aNizatidine Capsules USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-375-14nizatidine14 in 1 BOTTLECAPSULE141
21695-375-28nizatidine28 in 1 BOTTLECAPSULE281
21695-375-60nizatidine60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-375-14EA - Each21695-3752563682e-97e4-4885-9192-01844d68e3c212012-07-24
21695-375-28EA - Each21695-37506d819ab-7f53-4cc6-b068-de3733ea574912012-07-24
21695-375-60EA - Each21695-375683cd0ce-a274-4170-b723-df10258f596b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIZATIDINEACTIVE INGREDIENTP41PML4GHRNIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]1
NIZATIDINEACTIVE MOIETYP41PML4GHRNIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]1
DIMETHICONE 350INACTIVE INGREDIENT2Y53S6ATLUNIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XNIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-375NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 3 package rows20110121_0131d303-52c4-4ea7-a560-b529bb2c1616.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312025nizatidine 150 MG Oral CapsulePSN0131d303-52c4-4ea7-a560-b529bb2c16161
312025nizatidine 150 MG Oral CapsuleSCD0131d303-52c4-4ea7-a560-b529bb2c16161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-375-142169503751414 in 1 BOTTLEHistorical
21695-375-282169503752828 in 1 BOTTLEHistorical
21695-375-602169503756060 in 1 BOTTLEHistorical