Nizatidine

Product NDC: 0378-5150
11-digit product format: 003785150
Labeler code: 0378
Product ID: 0378-5150_1510df83-b013-4280-b49b-d0d2a23e86d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nizatidine
Dosage form: CAPSULE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA075806
Marketing category: ANDA
Marketing start: 2002-07-10
Marketing end: 2020-05-31
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: 0000-00-00
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	0378-5150		D	Discontinued by firm		2026-09-14
excluded package	package	0378-5150	0378-5150-91	D	Discontinued by firm		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 · 24 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	0378-5150-91	`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	0378-5150-91	`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	0378-5150-91	`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	0378-5150-91	`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	0378-5150-91	`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	0378-5150-91	`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	0378-5150-91	`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	0378-5150-91	`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	0378-5150-91	`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	0378-5150-91	`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	0378-5150-91	`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	0378-5150-91	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A075806-001	NIZATIDINE	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05
A075806-002	NIZATIDINE	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05

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	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL			2002-07-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL			2002-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075806-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075806-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	RS	2002-07-05	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075806-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075806-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075806-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075806-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075806-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075806-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075806-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075806-002	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-5150-05	EA - Each	0378-5150	2890806a-7e84-4c81-bf22-8422dcc72637	1	2012-07-24
0378-5150-91	EA - Each	0378-5150	3d12fad7-49ca-4248-b797-b3ff4c8fa7db	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NIZATIDINE	ACTIVE INGREDIENT	P41PML4GHR	NIZATIDINE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
NIZATIDINE	ACTIVE MOIETY	P41PML4GHR	NIZATIDINE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	NIZATIDINE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	NIZATIDINE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	NIZATIDINE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	NIZATIDINE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
DIMETHICONE 410	INACTIVE INGREDIENT	TYU5GP6XGE	NIZATIDINE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NIZATIDINE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	NIZATIDINE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NIZATIDINE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NIZATIDINE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	NIZATIDINE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NIZATIDINE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NIZATIDINE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
SHELLAC	INACTIVE INGREDIENT	46N107B71O	NIZATIDINE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NIZATIDINE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NIZATIDINE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NIZATIDINE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NIZATIDINE CAPSULE [MYLAN PHARMACEUTICALS INC.]	5

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nizatidine - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2016-10-26	HUMAN PRESCRIPTION DRUG LABEL	9