nizatidine

Product NDC: 21695-375
11-digit product format: 216950375
Labeler code: 21695
Product ID: 21695-375_0131d303-52c4-4ea7-a560-b529bb2c1616
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nizatidine
Dosage form: CAPSULE
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA076178
Marketing category: ANDA
Marketing start: 2002-07-05
Marketing end: 0000-00-00
Substance: NIZATIDINE
Active strength: 150 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-375		I	Inactivated by FDA	2026-09-14
excluded package	package	21695-375	21695-375-14	I	Inactivated by FDA	2026-09-14
excluded package	package	21695-375	21695-375-28	I	Inactivated by FDA	2026-09-14
excluded package	package	21695-375	21695-375-60	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 2 · 88 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	21695-375-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-375-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-375-28	`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	21695-375-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-375-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-375-28	`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	21695-375-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-375-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-375-28	`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	21695-375-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-375-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-375-28	`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	21695-375-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-375-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-375-28	`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	21695-375-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-375-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-375-28	`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	21695-375-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-375-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-375-28	`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	21695-375-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-375-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-375-28	`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	21695-375-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-375-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-375-28	`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	21695-375-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-375-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-375-28	`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	21695-375-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-375-14	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-375-28	`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	21695-375-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-375-14	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-375-28	`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	21695-375-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-375-14	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-375-28	`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	21695-375-60	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-375-14	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-375-28	`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	21695-375-60	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-375-14	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-375-28	`1332a3947898…`	`d4bfe170f9cd…`

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
A076178-001	NIZATIDINE	NIZATIDINE	150MG	CAPSULE / ORAL	AB		2002-07-05
A076178-002	NIZATIDINE	NIZATIDINE	300MG	CAPSULE / ORAL	AB		2002-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076178-001	AB
A076178-002	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076178-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2002-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076178-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2002-07-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076178-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2002-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076178-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2002-07-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076178-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2002-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076178-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2002-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076178-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2002-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076178-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2002-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076178-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2002-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076178-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2002-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076178-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2002-07-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076178-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2002-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076178-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2002-07-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076178-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2002-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076178-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2002-07-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076178-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2002-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076178-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2002-07-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076178-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2002-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076178-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2002-07-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076178-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2002-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076178-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2002-07-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076178-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2002-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076178-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2002-07-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076178-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2002-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076178-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2002-07-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076178-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2002-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076178-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2002-07-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076178-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2002-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076178-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2002-07-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076178-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2002-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076178-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2002-07-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076178-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2002-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076178-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2002-07-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076178-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2002-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076178-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2002-07-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076178-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2002-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076178-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2002-07-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076178-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2002-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076178-001	NIZATIDINE	150MG	CAPSULE / ORAL	AB	2002-07-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076178-002	NIZATIDINE	300MG	CAPSULE / ORAL	AB	2002-07-05	`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	A076178-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076178-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076178-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076178-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076178-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076178-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076178-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076178-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076178-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076178-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076178-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076178-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076178-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076178-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076178-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076178-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076178-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076178-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076178-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076178-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076178-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076178-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076178-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076178-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076178-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076178-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076178-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076178-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076178-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076178-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076178-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076178-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076178-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076178-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076178-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076178-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076178-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076178-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076178-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076178-002	AB	1	`74a2ff9319b5…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
21695-375-14	2019-09-24	C162847	48780-1	934fe258-4bae-48b1-e053-8cdaa90a720a	Nizatidine Capsules USP
21695-375-28	2019-09-24	C162847	48780-1	934fe258-4bae-48b1-e053-8cdaa90a720a	Nizatidine Capsules USP
21695-375-60	2019-09-24	C162847	48780-1	934fe258-4bae-48b1-e053-8cdaa90a720a	Nizatidine Capsules USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-375-14	nizatidine	14 in 1 BOTTLE	CAPSULE	14	1
21695-375-28	nizatidine	28 in 1 BOTTLE	CAPSULE	28	1
21695-375-60	nizatidine	60 in 1 BOTTLE	CAPSULE	60	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-375-14	EA - Each	21695-375	2563682e-97e4-4885-9192-01844d68e3c2	1	2012-07-24
21695-375-28	EA - Each	21695-375	06d819ab-7f53-4cc6-b068-de3733ea5749	1	2012-07-24
21695-375-60	EA - Each	21695-375	683cd0ce-a274-4170-b723-df10258f596b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NIZATIDINE	ACTIVE INGREDIENT	P41PML4GHR	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
NIZATIDINE	ACTIVE MOIETY	P41PML4GHR	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
DIMETHICONE 350	INACTIVE INGREDIENT	2Y53S6ATLU	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-375	NIZATIDINE CAPSULE [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 3 package rows	20110121_0131d303-52c4-4ea7-a560-b529bb2c1616.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	Epic Pharma, LLC	e9957997-8b85-48a0-9bb3-b878cb223236	2025-01-02	Adverse reactions	Exact identifier application applno (ANDA): 076178 application number: ANDA076178

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	0131d303-52c4-4ea7-a560-b529bb2c1616	1
312025	nizatidine 150 MG Oral Capsule	SCD	0131d303-52c4-4ea7-a560-b529bb2c1616	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-375-14	21695037514	14 in 1 BOTTLE	Historical
21695-375-28	21695037528	28 in 1 BOTTLE	Historical
21695-375-60	21695037560	60 in 1 BOTTLE	Historical