Tindamax

Product NDC: 0178-8500
11-digit product format: 001788500
Labeler code: 0178
Product ID: 0178-8500_d423971d-34c8-c7d2-e053-2a95a90abe74
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tinidazole
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mission Pharmacal Company
Application: NDA021618
Marketing category: NDA
Marketing start: 2004-05-17
Substance: TINIDAZOLE
Active strength: 500 mg/1
Pharmacologic classes: Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0178-8500	0178-8500-04	D	Discontinued by firm		2026-09-09

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 · 15 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 package	package	0178-8500-04	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0178-8500-04	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0178-8500-04	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0178-8500-04	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0178-8500-04	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0178-8500-04	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0178-8500-04	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0178-8500-04	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0178-8500-04	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0178-8500-04	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0178-8500-04	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0178-8500-04	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
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	0178-8500-20	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0178-8500-60	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021618-001	TINDAMAX	TINIDAZOLE	250MG	TABLET / ORAL	AB	RLD	2004-05-17
N021618-002	TINDAMAX	TINIDAZOLE	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021618-001	AB
N021618-002	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 · 84 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
2026-08-18 06:07:40	2026-07	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021618-001	TINDAMAX	250MG	TABLET / ORAL	AB	RLD	2004-05-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021618-002	TINDAMAX	500MG	TABLET / ORAL	AB	RLD, RS	2004-05-17	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021618-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021618-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021618-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021618-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021618-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021618-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021618-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021618-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021618-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021618-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021618-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021618-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021618-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021618-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021618-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021618-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021618-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021618-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021618-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021618-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021618-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021618-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021618-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021618-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021618-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021618-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021618-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021618-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021618-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021618-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021618-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021618-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021618-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021618-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021618-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021618-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021618-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021618-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021618-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021618-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TINIDAZOLE	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
033KF7V46H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199519	Internal RxNorm lookup
477234	Internal RxNorm lookup
539809	Internal RxNorm lookup
539811	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
a0d01539-8413-4703-94cc-d221918630a1	Available on FDA.report

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, Related label table
NDC	Effective	Related label
0178-8500-04	2020-10-15	Tindamax ® (tinidazole) oral tablets These highlights do not include all the information needed to use Tindamax ® safely and effectively. See full prescribing information for Tindamax. Tindamax ® (tinidazole) oral tablets for oral solution. Initial U.S. Approval 2004
0178-8500-20	2020-10-15	Tindamax ® (tinidazole) oral tablets These highlights do not include all the information needed to use Tindamax ® safely and effectively. See full prescribing information for Tindamax. Tindamax ® (tinidazole) oral tablets for oral solution. Initial U.S. Approval 2004
0178-8500-60	2020-10-15	Tindamax ® (tinidazole) oral tablets These highlights do not include all the information needed to use Tindamax ® safely and effectively. See full prescribing information for Tindamax. Tindamax ® (tinidazole) oral tablets for oral solution. Initial U.S. Approval 2004
0178-8500-04	2020-01-31	Tindamax ® (tinidazole) oral tablets These highlights do not include all the information needed to use Tindamax ® safely and effectively. See full prescribing information for Tindamax. Tindamax ® (tinidazole) oral tablets for oral solution. Initial U.S. Approval 2004
0178-8500-20	2020-01-31	Tindamax ® (tinidazole) oral tablets These highlights do not include all the information needed to use Tindamax ® safely and effectively. See full prescribing information for Tindamax. Tindamax ® (tinidazole) oral tablets for oral solution. Initial U.S. Approval 2004
0178-8500-60	2020-01-31	Tindamax ® (tinidazole) oral tablets These highlights do not include all the information needed to use Tindamax ® safely and effectively. See full prescribing information for Tindamax. Tindamax ® (tinidazole) oral tablets for oral solution. Initial U.S. Approval 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0178-8500-04	Tindamax	4 in 1 BOTTLE	TABLET, FILM COATED	4	9
0178-8500-20	Tindamax	20 in 1 BOTTLE	TABLET, FILM COATED	20	9
0178-8500-60	Tindamax	60 in 1 BOTTLE	TABLET, FILM COATED	60	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0178-8500-20	EA - Each	0178-8500	43d2526e-29d2-41be-a9df-e6bee208d453	1	2013-02-13
0178-8500-60	EA - Each	0178-8500	b4ce5c61-4c0b-4651-944b-f4cba85c34ca	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Tinidazole	ACTIVE INGREDIENT	033KF7V46H	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]	3
Tinidazole	ACTIVE MOIETY	033KF7V46H	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]	3
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]	3
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]	3
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]	3
TINIDAZOLE	ACTIVE INGREDIENT	033KF7V46H	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
TINIDAZOLE	ACTIVE MOIETY	033KF7V46H	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0178-8500	TINDAMAX (TINIDAZOLE) TABLET, FILM COATED [MISSION PHARMACAL COMPANY]	9	Current NDC, Legacy NDC, 3 package rows	20211228_a0d01539-8413-4703-94cc-d221918630a1.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	BioComp Pharma, Inc.	f55bcc41-2e8d-4ee5-9993-05c7d86f2d2c	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021618 application number: NDA021618
Tindamax	TINIDAZOLE	Mission Pharmacal Company	a0d01539-8413-4703-94cc-d221918630a1	2021-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021618 application number: NDA021618 ndc (product): 0178-8500

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
539809	TINDAMAX 250 MG Oral Tablet	PSN	a0d01539-8413-4703-94cc-d221918630a1	9
539811	TINDAMAX 500 MG Oral Tablet	PSN	a0d01539-8413-4703-94cc-d221918630a1	9
477234	tinidazole 250 MG Oral Tablet	PSN	a0d01539-8413-4703-94cc-d221918630a1	9
199519	tinidazole 500 MG Oral Tablet	PSN	a0d01539-8413-4703-94cc-d221918630a1	9
539809	tinidazole 250 MG Oral Tablet [Tindamax]	SBD	a0d01539-8413-4703-94cc-d221918630a1	9
539811	tinidazole 500 MG Oral Tablet [Tindamax]	SBD	a0d01539-8413-4703-94cc-d221918630a1	9
477234	tinidazole 250 MG Oral Tablet	SCD	a0d01539-8413-4703-94cc-d221918630a1	9
199519	tinidazole 500 MG Oral Tablet	SCD	a0d01539-8413-4703-94cc-d221918630a1	9
539809	TINDAMAX 250 MG Oral Tablet	SY	a0d01539-8413-4703-94cc-d221918630a1	9
539811	TINDAMAX 500 MG Oral Tablet	SY	a0d01539-8413-4703-94cc-d221918630a1	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0178-8500-04	00178850004	4 in 1 BOTTLE					Historical
0178-8500-20	00178850020	20 TABLET, FILM COATED in 1 BOTTLE (0178-8500-20)	2004-05-17	0000-00-00	No	No	Current
0178-8500-60	00178850060	60 TABLET, FILM COATED in 1 BOTTLE (0178-8500-60)	2004-05-17	0000-00-00	No	No	Current