Tinidazole

Product NDC: 53002-1611
Requested package NDC: 53002-1611-1
11-digit product format: 530021611
Labeler code: 53002
Product ID: 53002-1611_2d40e3ea-c6bb-4ddc-a3dd-f9085b596c67
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tinidazole
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA203808
Marketing category: ANDA
Marketing start: 2019-12-20
Marketing end: 0000-00-00
Substance: TINIDAZOLE
Active strength: 500 mg/1
Pharmacologic classes: Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53002-1611	53002-1611-1	I	Inactivated by FDA		2026-10-05

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 · 17 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2020-12-18 03:04 UTC · source 2020-12-17	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	`9bebd1f3094a…`	`5416666fcb17…`

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
A203808-001	TINIDAZOLE	TINIDAZOLE	250MG	TABLET / ORAL	AB		2015-08-04
A203808-002	TINIDAZOLE	TINIDAZOLE	500MG	TABLET / ORAL	AB		2015-08-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203808-001	AB
A203808-002	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	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203808-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2015-08-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203808-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2015-08-04	`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	A203808-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203808-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203808-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203808-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203808-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203808-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203808-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203808-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203808-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203808-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203808-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203808-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203808-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203808-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203808-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203808-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203808-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203808-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203808-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203808-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203808-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203808-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203808-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203808-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203808-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203808-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203808-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203808-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203808-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203808-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203808-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203808-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203808-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203808-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203808-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203808-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203808-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203808-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203808-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203808-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
53002-1611-1	2023-01-30	C162847	48780-1	9d75b9d1-1440-f424-e053-dadaa90a57ce	Tinidazole tablets for oral use These highlights do not include all the information needed to use tinidazole tablets safely and effectively. See full prescribing information for tinidazole tablets. Initial U.S. Approval: 2004
53002-1611-1	2020-12-15	C162847	48780-1	9d75b9d1-1440-f424-e053-dadaa90a57ce	Tinidazole tablets for oral use These highlights do not include all the information needed to use tinidazole tablets safely and effectively. See full prescribing information for tinidazole tablets. Initial U.S. Approval: 2004
53002-1611-1	2020-01-31	C162847	48780-1	9d75b9d1-1440-f424-e053-dadaa90a57ce	Tinidazole tablets for oral use These highlights do not include all the information needed to use tinidazole tablets safely and effectively. See full prescribing information for tinidazole tablets. Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-1611-1	Tinidazole	10 in 1 BOTTLE	TABLET	10		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-1611	TINIDAZOLE TABLET [RPK PHARMACEUTICALS, INC.]	3	Legacy NDC, 1 package rows	20201217_ebe89ab6-24c0-4214-853f-67e2e0c7daa9.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	REMEDYREPACK INC.	7f552a9b-3190-4301-8352-36451a73b956	2026-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203808 application number: ANDA203808
Tinidazole	TINIDAZOLE	Edenbridge Pharmaceuticals LLC.	6f3ce597-64c1-4204-a67a-8b6f6e7e8bca	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203808 application number: ANDA203808

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
199519	tinidazole 500 MG Oral Tablet	PSN	ebe89ab6-24c0-4214-853f-67e2e0c7daa9	3
199519	tinidazole 500 MG Oral Tablet	SCD	ebe89ab6-24c0-4214-853f-67e2e0c7daa9	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1611-1	53002161101	10 TABLET in 1 BOTTLE (53002-1611-1)	10 tablet	2019-12-20	0000-00-00	No	No	Current