Tinidazole

Product NDC: 40032-550
11-digit product format: 400320550
Labeler code: 40032
Product ID: 40032-550_530af487-7e0b-4ad5-a45b-3f7d9b1b71ae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tinidazole
Dosage form: TABLET
Route: ORAL
Labeler: Novel Laboratories, Inc.
Application: ANDA202044
Marketing category: ANDA
Marketing start: 2012-04-30
Marketing end: 0000-00-00
Substance: TINIDAZOLE
Active strength: 250 mg/1
Pharmacologic classes: Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	40032-550		I	Inactivated by FDA	2026-09-14
excluded package	package	40032-550	40032-550-08	I	Inactivated by FDA	2026-09-14
excluded package	package	40032-550	40032-550-40	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 · 66 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	40032-550-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	40032-550-40	`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	40032-550-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	40032-550-40	`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	40032-550-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	40032-550-40	`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	40032-550-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	40032-550-40	`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	40032-550-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	40032-550-40	`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	40032-550-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	40032-550-40	`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	40032-550-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	40032-550-40	`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	40032-550-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	40032-550-40	`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	40032-550-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	40032-550-40	`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	40032-550-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	40032-550-40	`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	40032-550-08	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	40032-550-40	`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	40032-550-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	40032-550-40	`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	40032-550-08	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	40032-550-40	`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	40032-550-08	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	40032-550-40	`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	40032-550-08	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	40032-550-40	`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	40032-550-08	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	40032-550-40	`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	40032-550-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	40032-550-40	`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	40032-550-08	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	40032-550-40	`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	40032-550-08	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	40032-550-40	`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	40032-550-08	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	40032-550-40	`e2bbac7714bc…`	`27bdfed8d636…`

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
A202044-001	TINIDAZOLE	TINIDAZOLE	250MG	TABLET / ORAL	AB		2012-04-30
A202044-002	TINIDAZOLE	TINIDAZOLE	500MG	TABLET / ORAL	AB		2012-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202044-001	AB
A202044-002	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	A202044-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202044-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202044-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202044-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202044-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202044-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202044-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202044-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202044-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202044-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202044-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202044-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202044-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202044-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202044-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202044-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202044-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202044-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202044-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202044-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202044-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202044-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202044-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202044-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202044-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202044-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202044-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202044-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202044-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202044-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202044-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202044-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202044-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202044-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202044-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202044-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202044-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202044-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202044-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202044-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`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	A202044-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202044-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202044-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202044-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202044-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202044-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202044-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202044-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202044-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202044-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202044-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202044-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202044-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202044-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202044-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202044-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202044-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202044-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202044-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202044-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202044-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202044-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202044-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202044-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202044-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202044-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202044-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202044-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202044-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202044-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202044-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202044-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202044-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202044-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202044-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202044-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202044-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202044-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202044-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202044-002	AB	1	`74a2ff9319b5…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f3ecf2e5-c042-aa76-e0af-284f60c6ce13	Product name	2	20150810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
40032-550-08	2020-01-31	C162847	48780-1	9d75b9d0-ef86-f424-e053-dadaa90a57ce	Tinidazole Tablets Novel Laboratories, Inc. These highlights do not include all the information needed to use Tinidazole safely and effectively. See full prescribing information for Tinidazole. Tinidazole (Tinidazole) TABLET for ORAL use. Initial U.S. Approval: 2004
40032-550-40	2020-01-31	C162847	48780-1	9d75b9d0-ef86-f424-e053-dadaa90a57ce	Tinidazole Tablets Novel Laboratories, Inc. These highlights do not include all the information needed to use Tinidazole safely and effectively. See full prescribing information for Tinidazole. Tinidazole (Tinidazole) TABLET for ORAL use. Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
40032-550-08	Tinidazole	8 in 1 BOTTLE	TABLET	8		3
40032-550-40	Tinidazole	40 in 1 BOTTLE	TABLET	40		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TINIDAZOLE	ACTIVE INGREDIENT	033KF7V46H	TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]	3
TINIDAZOLE	ACTIVE MOIETY	033KF7V46H	TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]	3
POLYETHYLENE GLYCOL 3000	INACTIVE INGREDIENT	SA1B764746	TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
40032-550	TINIDAZOLE TABLET [NOVEL LABORATORIES, INC.]	3	Legacy NDC, 2 package rows	20120529_4e03b4ac-c88a-4044-9d58-0cfcda3db53c.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tinidazole	TINIDAZOLE	Chartwell RX, LLC	b39bc167-f1c4-4169-8b46-e6c2eafe6bbf	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202044 application number: ANDA202044
Tinidazole	TINIDAZOLE	Lupin Pharmaceuticals,Inc.	95ab57b2-5d7e-4986-abcd-65edf1728383	2022-02-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202044 application number: ANDA202044

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
033KF7V46H	TINIDAZOLE	19387-91-8	TINIDAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
477234	tinidazole 250 MG Oral Tablet	PSN	4e03b4ac-c88a-4044-9d58-0cfcda3db53c	3
199519	tinidazole 500 MG Oral Tablet	PSN	4e03b4ac-c88a-4044-9d58-0cfcda3db53c	3
477234	tinidazole 250 MG Oral Tablet	SCD	4e03b4ac-c88a-4044-9d58-0cfcda3db53c	3
199519	tinidazole 500 MG Oral Tablet	SCD	4e03b4ac-c88a-4044-9d58-0cfcda3db53c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
40032-550-08	40032055008	8 in 1 BOTTLE	Historical
40032-550-40	40032055040	40 in 1 BOTTLE	Historical