Nizatidine

Product NDC: 68258-3006
11-digit product format: 682583006
Labeler code: 68258
Product ID: 68258-3006_26c7935e-4425-4a24-a7af-caa1db3585a1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nizatidine
Dosage form: CAPSULE
Route: ORAL
Labeler: Dispensing Solutions Inc.
Application: ANDA075616
Marketing category: ANDA
Marketing start: 2009-01-22
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68258-3006		I	Inactivated by FDA		2026-09-14
excluded package	package	68258-3006	68258-3006-1	I	Inactivated by FDA		2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68258-3006-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68258-3006-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68258-3006-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68258-3006-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68258-3006-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68258-3006-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68258-3006-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68258-3006-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68258-3006-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68258-3006-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68258-3006-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68258-3006-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68258-3006-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68258-3006-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68258-3006-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68258-3006-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68258-3006-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68258-3006-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68258-3006-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68258-3006-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68258-3006-1	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68258-3006-1	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075616-001	NIZATIDINE	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-09
A075616-002	NIZATIDINE	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075616-001	AB
A075616-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075616-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075616-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075616-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075616-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075616-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075616-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075616-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075616-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075616-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075616-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075616-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075616-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075616-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075616-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075616-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075616-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075616-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075616-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075616-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075616-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075616-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075616-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075616-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075616-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075616-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075616-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075616-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075616-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075616-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075616-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075616-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075616-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075616-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075616-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075616-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075616-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075616-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075616-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075616-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075616-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB		2002-07-09	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075616-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075616-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075616-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075616-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075616-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075616-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075616-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075616-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075616-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075616-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075616-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075616-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075616-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075616-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075616-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075616-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075616-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075616-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075616-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075616-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075616-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075616-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075616-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075616-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075616-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075616-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075616-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075616-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075616-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075616-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075616-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075616-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075616-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075616-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075616-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075616-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075616-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075616-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075616-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075616-002	AB	1	`74a2ff9319b5…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68258-3006-1	2019-10-21	C162847	48780-1	956f9ecf-de84-621f-e053-dbdaa90a74ad	Nizatidine Capsules USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68258-3006-1	Nizatidine	30 in 1 BOTTLE, PLASTIC	CAPSULE	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Nizatidine	ACTIVE INGREDIENT	P41PML4GHR	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
Nizatidine	ACTIVE MOIETY	P41PML4GHR	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	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
68258-3006	NIZATIDINE CAPSULE [DISPENSING SOLUTIONS INC.]	1	Legacy NDC, 1 package rows	20100315_3666b5f5-cdcf-42be-a67d-226603435d08.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nizatidine	NIZATIDINE	Actavis Pharma, Inc.	367a1004-59c1-4474-a4f6-ce8bf5a1b043	2022-06-30	Adverse reactions	Exact identifier application applno (ANDA): 075616 application number: ANDA075616

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
198041	nizatidine 300 MG Oral Capsule	PSN	3666b5f5-cdcf-42be-a67d-226603435d08	1
198041	nizatidine 300 MG Oral Capsule	SCD	3666b5f5-cdcf-42be-a67d-226603435d08	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68258-3006-1	68258300601	30 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nizatidine Capsules USP Rx only	Dispensing Solutions Inc.	2010-03-03	HUMAN PRESCRIPTION DRUG LABEL	1