metronidazole

Product NDC: 68071-2409
Requested package NDC: 68071-2409-4
11-digit product format: 680712409
Labeler code: 68071
Product ID: 68071-2409_10f6b5cd-3cf8-e2fe-e063-6394a90a690c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metronidazole
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA206560
Marketing category: ANDA
Marketing start: 2019-02-23
Substance: METRONIDAZOLE
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

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

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
A206560-001	METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2016-11-16
A206560-002	METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2016-11-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206560-001	AB
A206560-002	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.

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	A206560-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2016-11-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206560-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2016-11-16	`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	A206560-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206560-002	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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	d5784eeb-6b99-4e8a-847b-b0d1090ed48a	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	ST. MARY'S MEDICAL PARK PHARMACY	e3a32908-9db1-6ca7-e053-2a95a90a82fb	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	b49a8ad0-2cf9-4386-8bf5-1b1df87b0022	2026-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	Sportpharm LLC	dc8e448e-ac4e-4efc-8851-c368e31b9d69	2026-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	Preferred Pharmaceuticals Inc.	ab695a3e-1721-491a-97a2-c3f617a8d9fc	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	Northwind Health Company, LLC	06bd4afb-4a45-294c-e063-6394a90a7ab1	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	PD-Rx Pharmaceuticals, Inc.	8f1de4ca-a005-4ca9-a43a-380429c80d6f	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	356579f3-a9ed-49cf-bc0d-47b58a58cf85	2025-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	Viona Pharmaceuticals Inc	0f108035-d2ab-49c1-9f8d-daae11f0efe0	2024-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
METRONIDAZOLE	METRONIDAZOLE	Zydus Lifesciences Limited	f3ef765c-b531-4aaa-a86d-e32b7254ca48	2024-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	9e702861-87f5-4bc0-864d-317050020194	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	1030e723-cde9-44a7-8dab-2f0932ffcc2c	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	Asclemed USA, Inc.	89970965-a995-4ae4-a70b-bd2de38081e1	2024-04-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560
metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	c2dbfec8-da5b-cd2b-e053-2a95a90ad17c	2024-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206560 application number: ANDA206560 ndc (package): 68071-2409-4 ndc (product): 68071-2409 ndc11 (package): 68071240904

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METRONIDAZOLE	500 mg/1

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
311681	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
c2dbfec8-da5b-cd2b-e053-2a95a90ad17c	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
a5070875-62bb-61e1-fd46-8f7054197a40	Product name	8	20180215
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2409-1	2024-02-09	C162847	48780-1	f386c64a-1fd9-0266-e053-dadaa90a7c1a	Metronidazole Tablets, USP Rx only
68071-2409-2	2024-02-09	C162847	48780-1	f386c64a-1fd9-0266-e053-dadaa90a7c1a	Metronidazole Tablets, USP Rx only
68071-2409-3	2024-02-09	C162847	48780-1	f386c64a-1fd9-0266-e053-dadaa90a7c1a	Metronidazole Tablets, USP Rx only
68071-2409-4	2024-02-09	C162847	48780-1	f386c64a-1fd9-0266-e053-dadaa90a7c1a	Metronidazole Tablets, USP Rx only
68071-2409-5	2024-02-09	C162847	48780-1	f386c64a-1fd9-0266-e053-dadaa90a7c1a	Metronidazole Tablets, USP Rx only
68071-2409-7	2024-02-09	C162847	48780-1	f386c64a-1fd9-0266-e053-dadaa90a7c1a	Metronidazole Tablets, USP Rx only
68071-2409-8	2024-02-09	C162847	48780-1	f386c64a-1fd9-0266-e053-dadaa90a7c1a	Metronidazole Tablets, USP Rx only
68071-2409-9	2024-02-09	C162847	48780-1	f386c64a-1fd9-0266-e053-dadaa90a7c1a	Metronidazole Tablets, USP Rx only
68071-2409-1	2023-01-30	C162847	48780-1	f386c64a-1fd9-0266-e053-dadaa90a7c1a	Metronidazole Tablets, USP Rx only
68071-2409-2	2023-01-30	C162847	48780-1	f386c64a-1fd9-0266-e053-dadaa90a7c1a	Metronidazole Tablets, USP Rx only
68071-2409-3	2023-01-30	C162847	48780-1	f386c64a-1fd9-0266-e053-dadaa90a7c1a	Metronidazole Tablets, USP Rx only
68071-2409-4	2023-01-30	C162847	48780-1	f386c64a-1fd9-0266-e053-dadaa90a7c1a	Metronidazole Tablets, USP Rx only
68071-2409-5	2023-01-30	C162847	48780-1	f386c64a-1fd9-0266-e053-dadaa90a7c1a	Metronidazole Tablets, USP Rx only
68071-2409-7	2023-01-30	C162847	48780-1	f386c64a-1fd9-0266-e053-dadaa90a7c1a	Metronidazole Tablets, USP Rx only
68071-2409-8	2023-01-30	C162847	48780-1	f386c64a-1fd9-0266-e053-dadaa90a7c1a	Metronidazole Tablets, USP Rx only
68071-2409-9	2023-01-30	C162847	48780-1	f386c64a-1fd9-0266-e053-dadaa90a7c1a	Metronidazole Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-2409-1	metronidazole	4 in 1 BOTTLE	TABLET	4	2
68071-2409-2	metronidazole	21 in 1 BOTTLE	TABLET	21	2
68071-2409-3	metronidazole	30 in 1 BOTTLE	TABLET	30	2
68071-2409-4	metronidazole	14 in 1 BOTTLE	TABLET	14	2
68071-2409-5	metronidazole	40 in 1 BOTTLE	TABLET	40	2
68071-2409-7	metronidazole	20 in 1 BOTTLE	TABLET	20	2
68071-2409-8	metronidazole	28 in 1 BOTTLE	TABLET	28	2
68071-2409-9	metronidazole	90 in 1 BOTTLE	TABLET	90	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2409	METRONIDAZOLE TABLET [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, Legacy NDC, 8 package rows	20240210_c2dbfec8-da5b-cd2b-e053-2a95a90ad17c.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
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	c2dbfec8-da5b-cd2b-e053-2a95a90ad17c	2
311681	metronidazole 500 MG Oral Tablet	SCD	c2dbfec8-da5b-cd2b-e053-2a95a90ad17c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2409-4	68071240904	14 TABLET in 1 BOTTLE (68071-2409-4)	14 tablet	2021-05-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Tablets, USP Rx only	NuCare Pharmaceuticals,Inc.	2024-02-09	HUMAN PRESCRIPTION DRUG LABEL	2