Nizatidine

Product NDC: 0591-3138
11-digit product format: 005913138
Labeler code: 0591
Product ID: 0591-3138_0920fca7-e74b-49fb-809b-ef720690752e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nizatidine
Dosage form: CAPSULE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA075616
Marketing category: ANDA
Marketing start: 2002-07-09
Substance: NIZATIDINE
Active strength: 300 mg/1
Pharmacologic classes: Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Nizatidine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NIZATIDINE	300 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	P41PML4GHR
Rxcui	198041, 312025

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-3138-30	Nizatidine	30 in 1 BOTTLE, PLASTIC	CAPSULE	30		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-3138-30	EA - Each	0591-3138	fcfdd576-67ba-43f9-a040-0bb4b2a8a481	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NIZATIDINE	ACTIVE INGREDIENT	P41PML4GHR	NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.]	2
NIZATIDINE	ACTIVE MOIETY	P41PML4GHR	NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.]	2
FERRIC OXIDE BLACK	INACTIVE INGREDIENT	XM0M87F357	NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.]	2
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NIZATIDINE CAPSULE [WATSON LABORATORIES, INC.]	2
Nizatidine	ACTIVE INGREDIENT	P41PML4GHR	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
NIZATIDINE	ACTIVE INGREDIENT	P41PML4GHR	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
Nizatidine	ACTIVE MOIETY	P41PML4GHR	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
NIZATIDINE	ACTIVE MOIETY	P41PML4GHR	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	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 RED	INACTIVE INGREDIENT	1K09F3G675	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-3138	NIZATIDINE CAPSULE [ACTAVIS PHARMA, INC.]	9	Current NDC, Legacy NDC, 1 package rows	20241228_367a1004-59c1-4474-a4f6-ce8bf5a1b043.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312025	nizatidine 150 MG Oral Capsule	PSN	367a1004-59c1-4474-a4f6-ce8bf5a1b043	9
198041	nizatidine 300 MG Oral Capsule	PSN	367a1004-59c1-4474-a4f6-ce8bf5a1b043	9
312025	nizatidine 150 MG Oral Capsule	SCD	367a1004-59c1-4474-a4f6-ce8bf5a1b043	9
198041	nizatidine 300 MG Oral Capsule	SCD	367a1004-59c1-4474-a4f6-ce8bf5a1b043	9
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-3138-00	00591313800	19000 CAPSULE in 1 BAG (0591-3138-00)	19000 capsule	09-JUL-02				Current
0591-3138-30	00591313830	30 CAPSULE in 1 BOTTLE, PLASTIC (0591-3138-30)	30 capsule	2002-07-09	0000-00-00	No	No	Current
0591-3138-77	00591313877	9330 CAPSULE in 1 CONTAINER (0591-3138-77)	9330 capsule	17-SEP-24				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nizatidine Capsules, USP Rx only	Actavis Pharma, Inc.	2022-06-30	HUMAN PRESCRIPTION DRUG LABEL	9
Nizatidine Capsules 300 mg	Rebel Distributors Corp	2012-02-09	HUMAN PRESCRIPTION DRUG LABEL	1

Nizatidine

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#