Metronidazole

Product NDC: 16571-664
11-digit product format: 165710664
Labeler code: 16571
Product ID: 16571-664_241c7c4c-5fd9-4c0e-b7b7-4094f77e9721
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metronidazole
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA203974
Marketing category: ANDA
Marketing start: 2015-05-29
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
A203974-001	METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29
A203974-002	METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203974-001	AB
A203974-002	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	A203974-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2015-05-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203974-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	RS	2015-05-29	`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	A203974-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203974-002	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	c225a455-ec25-2213-e053-2995a90a3389	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203974 application number: ANDA203974
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	dc28753c-95ec-4b41-ad77-c4a66698d9db	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203974 application number: ANDA203974
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	2fa14353-45df-429c-8759-7d66a65f08f0	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203974 application number: ANDA203974
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	92e58420-1d99-4a92-b1f3-a7f791ca7187	2024-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203974 application number: ANDA203974
Metronidazole	METRONIDAZOLE	Rising Pharma Holdings, Inc.	93e4f174-4fe0-4cfd-a0cf-d0963e082107	2024-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203974 application number: ANDA203974 ndc (product): 16571-664
Metronidazole	METRONIDAZOLE	Aurobindo Pharma Limited	f68397ee-67db-472e-8607-4300064e37df	2024-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203974 application number: ANDA203974
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	bff2f5bd-75a4-4252-a643-c21741ae8a96	2023-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203974 application number: ANDA203974

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311681	Internal RxNorm lookup
314106	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
93e4f174-4fe0-4cfd-a0cf-d0963e082107	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	Strength	SPL version
16571-664-01	Metronidazole	100 in 1 BOTTLE	TABLET	100		7
16571-664-50	Metronidazole	500 in 1 BOTTLE	TABLET	500		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-664-01	EA - Each	16571-664	621283af-b128-4c8e-843c-47fa4bf37b62	1	2020-06-05
16571-664-50	EA - Each	16571-664	9c8e4271-aa76-4c95-8434-26ed5d12d13d	1	2020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-664	METRONIDAZOLE TABLET [RISING PHARMA HOLDINGS, INC.]	7	Current NDC, Legacy NDC, 2 package rows	20241015_93e4f174-4fe0-4cfd-a0cf-d0963e082107.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	92e58420-1d99-4a92-b1f3-a7f791ca7187	105
311681	metronidazole 500 MG Oral Tablet	SCD	92e58420-1d99-4a92-b1f3-a7f791ca7187	105
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	dc28753c-95ec-4b41-ad77-c4a66698d9db	13
311681	metronidazole 500 MG Oral Tablet	SCD	dc28753c-95ec-4b41-ad77-c4a66698d9db	13
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	93e4f174-4fe0-4cfd-a0cf-d0963e082107	7
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	93e4f174-4fe0-4cfd-a0cf-d0963e082107	7
314106	metronidazole 250 MG Oral Tablet	SCD	93e4f174-4fe0-4cfd-a0cf-d0963e082107	7
311681	metronidazole 500 MG Oral Tablet	SCD	93e4f174-4fe0-4cfd-a0cf-d0963e082107	7
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	b9c0674b-00c9-5989-e053-2995a90ac1bb	3
311681	metronidazole 500 MG Oral Tablet	SCD	b9c0674b-00c9-5989-e053-2995a90ac1bb	3
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	0949690c-28ce-8241-e063-6394a90a1363	2
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	ba73a050-9a5c-1549-e053-2a95a90a62aa	2
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	c225a455-ec25-2213-e053-2995a90a3389	2
311681	metronidazole 500 MG Oral Tablet	SCD	ba73a050-9a5c-1549-e053-2a95a90a62aa	2
311681	metronidazole 500 MG Oral Tablet	SCD	c225a455-ec25-2213-e053-2995a90a3389	2
311681	metronidazole 500 MG Oral Tablet	SCD	0949690c-28ce-8241-e063-6394a90a1363	2
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	8ed090d4-363f-4e67-8ccd-e8c74a32e209	1
311681	metronidazole 500 MG Oral Tablet	SCD	8ed090d4-363f-4e67-8ccd-e8c74a32e209	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16571-664-01	16571066401	100 TABLET in 1 BOTTLE (16571-664-01)	100 tablet	2015-05-29	0000-00-00	No	No	Current
16571-664-50	16571066450	500 TABLET in 1 BOTTLE (16571-664-50)	500 tablet	2015-05-29	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.	2026-03-13	HUMAN PRESCRIPTION DRUG LABEL	2
Metronidazole Tablets USP Rx only	REMEDYREPACK INC.	2026-02-13	HUMAN PRESCRIPTION DRUG LABEL	13
Metronidazole Tablets USP Rx only	Bryant Ranch Prepack	2024-10-31	HUMAN PRESCRIPTION DRUG LABEL	105
Metronidazole Tablets USP Rx only	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2024-09-04	Human Prescription Drug Label	7
Metronidazole 500MG Tablets Rx only	RedPharm Drug, Inc. \| RedPharm Drug	2024-08-07	HUMAN PRESCRIPTION DRUG LABEL	3
Metronidazole 500mg Tablets USP Rx only	Pharmasource Meds, LLC	2024-05-28	HUMAN PRESCRIPTION DRUG LABEL	2
Metronidazole Tablets USP Rx only	A-S Medication Solutions	2023-12-09	Human Prescription Drug Label	6
Metronidazole Tablets USP Rx only	A-S Medication Solutions	2023-11-24	Human Prescription Drug Label	5
Metronidazole Tablets USP Rx only	NuCare Pharmaceuticals,Inc.	2023-09-22	HUMAN PRESCRIPTION DRUG LABEL	2
Metronidazole Tablets USP Rx only	A-S Medication Solutions	2023-02-06	Human Prescription Drug Label	5
Metronidazole Tablets USP Rx only	A-S Medication Solutions	2023-02-06	Human Prescription Drug Label	3
Metronidazole Tablets USP Rx only	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-12	HUMAN PRESCRIPTION DRUG LABEL	2
Metronidazole Tablets USP Rx only	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	2
Metronidazole Tablets USP Rx only	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	1
Metronidazole Tablets USP Rx only	Quality Care Products, LLC	2022-08-24	Human Prescription Drug Label	7
Metronidazole Tablets USP Rx only	RPK Pharmaceuticals, Inc.	2022-03-30	Human Prescription Drug Label	1
Metronidazole Tablets USP Rx only	St. Mary's Medical Park Pharmacy	2021-05-11	HUMAN PRESCRIPTION DRUG LABEL	2