Nizatidine

Product NDC: 0591-3137
11-digit product format: 005913137
Labeler code: 0591
Product ID: 0591-3137_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: 150 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	150 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
0591-3137-60	Nizatidine	60 in 1 BOTTLE, PLASTIC	CAPSULE	60		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-3137-60	EA - Each	0591-3137	ef79d546-e383-4f9a-a659-185f89244f76	1	2012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-3137	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
312025	nizatidine 150 MG Oral Capsule	PSN	005909e4-77d2-440f-a10b-30fab27ffbc3	4
312025	nizatidine 150 MG Oral Capsule	SCD	005909e4-77d2-440f-a10b-30fab27ffbc3	4
312025	nizatidine 150 MG Oral Capsule	PSN	33cf4324-44cb-44df-b459-7319a335b253	1
312025	nizatidine 150 MG Oral Capsule	PSN	565fcd92-6f4a-4060-be06-3001159264d9	1
312025	nizatidine 150 MG Oral Capsule	SCD	33cf4324-44cb-44df-b459-7319a335b253	1
312025	nizatidine 150 MG Oral Capsule	SCD	565fcd92-6f4a-4060-be06-3001159264d9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-3137-00	00591313700	36000 CAPSULE in 1 BAG (0591-3137-00)	36000 capsule	29-OCT-24				Current
0591-3137-60	00591313760	60 CAPSULE in 1 BOTTLE, PLASTIC (0591-3137-60)	60 capsule	2002-07-09	0000-00-00	No	No	Current
0591-3137-77	00591313777	17795 CAPSULE in 1 CONTAINER (0591-3137-77)	17795 capsule	29-OCT-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 150 mg and 300 mg	Carilion Materials Management	2017-07-06	HUMAN PRESCRIPTION DRUG LABEL	4
Nizatidine Capsules 150 mg and 300 mg	Rebel Distributors Corp	2012-02-09	HUMAN PRESCRIPTION DRUG LABEL	1
Nizatidine Capsules 150 mg and 300 mg	H.J. Harkins Company, Inc. \| Watson Laboratories, Inc. \| SGS Life Science Services \| Watson Laboratories, Inc. - Florida \| Watson Pharma Private Limited \| Whitehouse Analytical Laboratories	2011-10-12	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#