NIZATIDINE

Product NDC: 60846-301
11-digit product format: 608460301
Labeler code: 60846
Product ID: 60846-301_aedc4160-2165-451e-8a3b-26d3bb911242
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NIZATIDINE
Dosage form: SOLUTION
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA090576
Marketing category: ANDA
Marketing start: 2016-08-12
Substance: NIZATIDINE
Active strength: 15 mg/mL
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

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 · 10 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
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	60846-301-15	`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	60846-301-15	`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	60846-301-15	`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	60846-301-15	`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	60846-301-15	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090576-001	NIZATIDINE	NIZATIDINE	15MG/ML	SOLUTION / ORAL			2009-11-18

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL	RS	2009-11-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090576-001	NIZATIDINE	15MG/ML	SOLUTION / ORAL		2009-11-18	`f41ea6bd6efb…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NIZATIDINE	15 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
P41PML4GHR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
476872	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
39e62997-8781-449a-e054-00144ff88e88	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
60846-301-15	2024-10-22	C162847	48780-1	1030e365-283c-111a-e063-dadaa90a10e2	Nizatidine Oral Solution 15 mg/mL Rx only
60846-301-15	2024-01-30	C162847	48780-1	1030e365-283c-111a-e063-dadaa90a10e2	Nizatidine Oral Solution 15 mg/mL Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60846-301-15	NIZATIDINE	480 mL in 1 BOTTLE	SOLUTION	480		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60846-301-15	ML - Milliliter	60846-301	66f592e9-aada-4660-88d7-bad779271d56	1	2016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60846-301	NIZATIDINE SOLUTION [AMNEAL PHARMACEUTICALS LLC]	9	Current NDC, Legacy NDC, 1 package rows	20241025_39e62997-8781-449a-e054-00144ff88e88.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	Amneal Pharmaceuticals LLC	39e62997-8781-449a-e054-00144ff88e88	2024-10-23	Adverse reactions	Exact identifier application applno (ANDA): 090576 application number: ANDA090576 ndc (product): 60846-301

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
476872	nizatidine 75 MG in 5 mL Oral Solution	PSN	39e62997-8781-449a-e054-00144ff88e88	9
476872	nizatidine 15 MG/ML Oral Solution	SCD	39e62997-8781-449a-e054-00144ff88e88	9
476872	nizatidine 75 MG per 5 ML Oral Solution	SY	39e62997-8781-449a-e054-00144ff88e88	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60846-301-15	60846030115	480 mL in 1 BOTTLE (60846-301-15)	480 ml	2016-08-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nizatidine Oral Solution 15 mg/mL Rx only	Amneal Pharmaceuticals LLC	2024-10-23	HUMAN PRESCRIPTION DRUG LABEL	9