Metronidazole

Product NDC: 51672-4164
Requested package NDC: 51672-4164-6
11-digit product format: 516724164
Labeler code: 51672
Product ID: 51672-4164_6f4c6a7f-eee9-45b2-b0ed-64377aab9d49
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metronidazole
Dosage form: GEL
Route: TOPICAL
Labeler: Taro Pharmaceuticals U.S.A., Inc.
Application: ANDA204651
Marketing category: ANDA
Marketing start: 2017-03-14
Substance: METRONIDAZOLE
Active strength: 10 mg/g
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	51672-4164	51672-4164-6	D	Discontinued by firm		2026-08-17

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 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204651-001	METRONIDAZOLE	METRONIDAZOLE	1%	GEL / TOPICAL	AB		2017-03-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204651-001	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 2 · 42 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
2026-08-18 06:07:40	2026-07	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB	2017-03-14	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A204651-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204651-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204651-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204651-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204651-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204651-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204651-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204651-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204651-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204651-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204651-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204651-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204651-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204651-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204651-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204651-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204651-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204651-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204651-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204651-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204651-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204651-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204651-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204651-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204651-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204651-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204651-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204651-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204651-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204651-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204651-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204651-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204651-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204651-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204651-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204651-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204651-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204651-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204651-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204651-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Metronidazole
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METRONIDAZOLE	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
140QMO216E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
577237	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
5a504f74-bccd-433a-bd5b-6822f98c34df	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55	Product name	5	20251024
7f6d14e0-4366-41bc-a4a9-b74c79a20e17	Product name	1	20250623
e6d321b0-0e5e-7da6-f043-92b6a91f00a1	Product name	5	20250515
e1aac33b-94ae-4ee9-905b-299f7263853b	Product name	3	20250124
16642716-d28a-4f90-8dcb-3921cd8c8109	Product name	4	20240516
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15	Product name	1	20240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
a5070875-62bb-61e1-fd46-8f7054197a40	Product name	8	20180215
0add4de9-d152-3375-3390-1123dddc5e3d	Product name	1	20140508
33ca0fcc-1011-92dc-50a9-a383683eed1e	Product name	1	20140508
53f39d9f-cd3f-04e1-c668-d4580719d57d	Product name	1	20140508
a804000f-b74f-0b5d-d17b-aa767c286ddb	Product name	1	20140508
a91ea265-6e02-c08f-93c8-686d54180529	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51672-4164-3	Metronidazole	1 in 1 CARTON	GEL	1	6
51672-4164-3	Metronidazole	60 g in 1 TUBE	GEL	60	6
51672-4164-6	Metronidazole	1 in 1 CARTON	GEL	1	6
51672-4164-6	Metronidazole	45 g in 1 TUBE	GEL	45	6
51672-4164-9	Metronidazole	55 g in 1 BOTTLE, PUMP	GEL	55	6
51672-4164-9	Metronidazole	1 in 1 CARTON	GEL	1	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-4164-3	GM - Gram	51672-4164	7478a107-2b52-4b1e-bcaa-bb66a0fa5555	1	2017-04-05
51672-4164-9	GM - Gram	51672-4164	67ab368e-2499-4522-bc1c-fa9198290fe2	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-4164	METRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.]	6	Current NDC, Legacy NDC, 6 package rows	20190510_5a504f74-bccd-433a-bd5b-6822f98c34df.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
Metronidazole	METRONIDAZOLE	Sun Pharmaceutical Industries, Inc.	5a504f74-bccd-433a-bd5b-6822f98c34df	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204651 application number: ANDA204651 ndc (package): 51672-4164-6 ndc (product): 51672-4164 ndc11 (package): 51672416406
Metronidazole	METRONIDAZOLE	Sun Pharmaceutical Industries, Inc.	5842a554-58d1-4ee4-99aa-1e6029a69be2	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204651 application number: ANDA204651

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
140QMO216E	METRONIDAZOLE	443-48-1	METRONIDAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
577237	metroNIDAZOLE 1 % Topical Gel	PSN	5a504f74-bccd-433a-bd5b-6822f98c34df	6
577237	metronidazole 0.01 MG/MG Topical Gel	SCD	5a504f74-bccd-433a-bd5b-6822f98c34df	6
577237	metronidazole 1 % Topical Gel	SY	5a504f74-bccd-433a-bd5b-6822f98c34df	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-4164-6	51672416406	1 TUBE in 1 CARTON (51672-4164-6) / 45 g in 1 TUBE	1 tube	2017-03-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole	Sun Pharmaceutical Industries, Inc. \| Taro Pharmaceutical Industries Ltd.	2026-07-15	HUMAN PRESCRIPTION DRUG LABEL	7