Tinidazole

Product NDC: 0054-0348
Requested package NDC: 0054-0348-07
11-digit product format: 000540348
Labeler code: 0054
Product ID: 0054-0348_44dc735d-c062-4a4d-a74d-3823b461efcf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tinidazole
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA201172
Marketing category: ANDA
Marketing start: 2012-04-30
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: 2023-12-31
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	0054-0348	0054-0348-07	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 · 12 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…`

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
A201172-001	TINIDAZOLE	TINIDAZOLE	250MG	TABLET / ORAL			2012-04-30
A201172-002	TINIDAZOLE	TINIDAZOLE	500MG	TABLET / ORAL			2012-04-30

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	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL		2012-04-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL		2012-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201172-001	TINIDAZOLE	250MG	TABLET / ORAL	AB	2012-04-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201172-002	TINIDAZOLE	500MG	TABLET / ORAL	AB	2012-04-30	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201172-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201172-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201172-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201172-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201172-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201172-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201172-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201172-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201172-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201172-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201172-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201172-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201172-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201172-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201172-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201172-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201172-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201172-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201172-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201172-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201172-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201172-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201172-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201172-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201172-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201172-002	AB	1	`ea99ee380514…`
2022-09-29 23:25 UTC	2022-09	A201172-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A201172-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201172-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201172-002	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0348-07	EA - Each	0054-0348	5f06f183-3b09-4b9c-918a-eaee7657605c	1	2012-07-24
0054-0348-21	EA - Each	0054-0348	fc69abd7-49f4-464b-bf1e-0b510b96bd05	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TINIDAZOLE	ACTIVE INGREDIENT	033KF7V46H	TINIDAZOLE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	1
TINIDAZOLE	ACTIVE MOIETY	033KF7V46H	TINIDAZOLE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TINIDAZOLE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	TINIDAZOLE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TINIDAZOLE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TINIDAZOLE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	TINIDAZOLE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TINIDAZOLE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	1
POVIDONE K12	INACTIVE INGREDIENT	333AG72FWJ	TINIDAZOLE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TINIDAZOLE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TINIDAZOLE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	TINIDAZOLE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TINIDAZOLE TABLET, FILM COATED [ROXANE LABORATORIES, INC]	1

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	9719883b-496d-42bb-e053-2995a90a1ab1	6
199519	tinidazole 500 MG Oral Tablet	SCD	9719883b-496d-42bb-e053-2995a90a1ab1	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0348-07	00054034807	20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07)	2012-04-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tinidazole	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2021-12-30	HUMAN PRESCRIPTION DRUG LABEL	6
Tinidazole 500mg	RedPharm Drug, Inc.	2021-01-14	HUMAN PRESCRIPTION DRUG LABEL	6