Metronidazole

Product NDC: 51672-4164
Requested package NDC: 51672-4164-9
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	51672-4164-9	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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.

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
2026-08-01 22:54:32	2026-06	A204651-001	METRONIDAZOLE	1%	GEL / TOPICAL	AB		2017-03-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A204651-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 51672-4164-9 ndc (product): 51672-4164 ndc11 (package): 51672416409
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

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

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	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-4164-9	51672416409	1 BOTTLE, PUMP in 1 CARTON (51672-4164-9) / 55 g in 1 BOTTLE, PUMP	2017-08-15	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