Tindazole

Product NDC: 16571-214
11-digit product format: 165710214
Labeler code: 16571
Product ID: 16571-214_3a66b537-63a4-41f9-8415-5ed05bd8cbcf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tinidazole
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Pack Pharmaceuticals, LLC
Application: ANDA202489
Marketing category: ANDA
Marketing start: 2013-10-09
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: 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	16571-214		D	Discontinued by firm		2026-09-14
excluded package	package	16571-214	16571-214-04	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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16571-214-04	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16571-214-04	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16571-214-04	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16571-214-04	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16571-214-04	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16571-214-04	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16571-214-04	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16571-214-04	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16571-214-04	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16571-214-04	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16571-214-04	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16571-214-04	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	16571-214-04	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	16571-214-04	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	16571-214-04	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	16571-214-04	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	16571-214-04	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	16571-214-04	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	16571-214-04	I	Inactivated by FDA	`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
A202489-001	TINIDAZOLE	TINIDAZOLE	250MG	TABLET / ORAL	AB		2013-10-09
A202489-002	TINIDAZOLE	TINIDAZOLE	500MG	TABLET / ORAL	AB		2013-10-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202489-001	AB
A202489-002	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	A202489-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2013-10-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202489-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2013-10-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202489-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2013-10-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202489-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2013-10-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202489-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2013-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202489-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2013-10-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202489-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2013-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202489-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2013-10-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202489-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2013-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202489-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2013-10-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202489-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2013-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202489-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2013-10-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202489-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2013-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202489-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2013-10-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202489-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2013-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202489-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2013-10-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202489-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2013-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202489-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2013-10-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202489-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2013-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202489-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2013-10-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202489-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2013-10-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202489-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2013-10-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202489-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2013-10-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202489-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2013-10-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202489-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2013-10-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202489-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2013-10-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202489-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2013-10-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202489-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2013-10-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202489-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2013-10-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202489-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2013-10-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202489-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2013-10-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202489-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2013-10-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202489-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2013-10-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202489-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2013-10-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202489-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2013-10-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202489-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2013-10-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202489-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2013-10-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202489-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2013-10-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202489-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2013-10-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202489-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2013-10-09	`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	A202489-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202489-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202489-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202489-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202489-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202489-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202489-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202489-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202489-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202489-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202489-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202489-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202489-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202489-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202489-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202489-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202489-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202489-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202489-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202489-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202489-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202489-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202489-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202489-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202489-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202489-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202489-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202489-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202489-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202489-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202489-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202489-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202489-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202489-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202489-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202489-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202489-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202489-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202489-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202489-002	AB	1	`74a2ff9319b5…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
16571-214-04	2024-03-05	C162847	48780-1	9855e2a2-4335-60a7-e053-dbdaa90a05bd	These highlights do not include all the information needed to use Tinidazole Tablets safely and effectively. See full prescribing information for Tinidazole Tablets Tinidazole Tablets, for oral use Initial U.S. Approval: 2004
16571-214-04	2019-11-27	C162847	48780-1	9855e2a2-4335-60a7-e053-dbdaa90a05bd	These highlights do not include all the information needed to use Tinidazole Tablets safely and effectively. See full prescribing information for Tinidazole Tablets Tinidazole Tablets, for oral use Initial U.S. Approval: 2004

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TINIDAZOLE	ACTIVE INGREDIENT	033KF7V46H	TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED [PACK PHARMACEUTICALS, LLC]	2
TINIDAZOLE	ACTIVE MOIETY	033KF7V46H	TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED [PACK PHARMACEUTICALS, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED [PACK PHARMACEUTICALS, LLC]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED [PACK PHARMACEUTICALS, LLC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED [PACK PHARMACEUTICALS, LLC]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED [PACK PHARMACEUTICALS, LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED [PACK PHARMACEUTICALS, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED [PACK PHARMACEUTICALS, LLC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED [PACK PHARMACEUTICALS, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED [PACK PHARMACEUTICALS, LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED [PACK PHARMACEUTICALS, LLC]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED TINDAZOLE (TINIDAZOLE) TABLET, FILM COATED [PACK PHARMACEUTICALS, LLC]	2

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
Tindazole	TINIDAZOLE	REMEDYREPACK INC.	45fa3ebd-52da-4987-82a1-4a64f99785a7	2026-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202489 application number: ANDA202489
Tindazole	TINIDAZOLE	Rising Pharma Holdings, Inc.	32167dd7-5d37-457b-9b00-cd735de6b060	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202489 application number: ANDA202489