Nizatidine

Product NDC: 21695-043
11-digit product format: 216950043
Labeler code: 21695
Product ID: 21695-043_487b4138-f7db-480f-96d2-8010fd5c0c06
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nizatidine
Dosage form: CAPSULE
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA075616
Marketing category: ANDA
Marketing start: 2002-07-09
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 concept	Relation	Version	Effective
5c362336-b506-4bdc-6f70-74c97a4a3342	Product name	1	20140508
6f755c6f-b906-f8da-e39d-305610ef9195	Product name	1	20140508

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-043-30	2019-09-24	C162847	48780-1	934fe258-4d28-48b1-e053-8cdaa90a720a	Nizatidine Capsules 300 mg

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-043-30	Nizatidine	30 in 1 BOTTLE, PLASTIC	CAPSULE	30		1

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-043-30	EA - Each	21695-043	7b45d13c-dd71-4f4a-8861-535108197904	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NIZATIDINE	ACTIVE INGREDIENT	P41PML4GHR	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
NIZATIDINE	ACTIVE MOIETY	P41PML4GHR	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-043	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20120420_487b4138-f7db-480f-96d2-8010fd5c0c06.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P41PML4GHR	NIZATIDINE	76963-41-2	NIZATIDINE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198041	nizatidine 300 MG Oral Capsule	PSN	487b4138-f7db-480f-96d2-8010fd5c0c06	1
198041	nizatidine 300 MG Oral Capsule	SCD	487b4138-f7db-480f-96d2-8010fd5c0c06	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-043-30	21695004330	30 in 1 BOTTLE, PLASTIC	Historical